Accord Healthcare Inc.

• LevothyroxineTirosint, Tirosint Sol, Synthroid · 12 products
• QuetiapineSeroquel, Seroquel XR · 11 products
• Ropinirole7 products
• AripiprazoleAbilify, Opipza, Abilify Asimtufii · 6 products
• LenalidomideRevlimid · 6 products
• TemozolomideTemodar · 6 products
• Lurasidone hydrochlorideLatuda · 5 products
• SimvastatinZocor · 5 products
• TacrolimusPrograf, Envarsus XR, Astagraf XL · 5 products
• BuspironeBucapsol · 5 products
• AtorvastatinLipitor · 4 products
• Trazodone hydrochlorideRaldesy Tm · 4 products
• Hydroxychloroquine sulfatePlaquenil, Sovuna · 4 products
• Pravastatin sodium4 products
• TadalafilCialis, Tadliq, Adcirca · 4 products
• GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 4 products
• AtropineAtropen Auto-Injector, Isopto Atropine · 4 products
• DoxazosinCardura, Cardura XL · 4 products
• RosuvastatinCrestor · 4 products
• Glimepiride3 products
• Vilazodone hydrochlorideViibryd · 3 products
• CinacalcetSensipar · 3 products
• DofetilideTikosyn · 3 products
• FurosemideLasix, Furoscix, Lasix Onyu · 3 products
• Amitriptyline hydrochloride3 products
• PemetrexedPemrydi Rtu, Alimta, Pemfexy · 3 products
• OxybutyninOxytrol · 3 products
• MitomycinMutamycin · 3 products
• Sertraline hydrochlorideZoloft · 3 products
• FluorouracilFavlyxa, Tolak, Efudex · 3 products
• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
• DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 3 products
• MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 3 products
• ClonazepamKlonopin · 3 products
• EscitalopramLexapro · 3 products
• HydrochlorothiazideInzirqo · 3 products
• SpironolactoneAldactone · 3 products
• Olmesartan medoxomilBenicar · 3 products
• Mycophenolate mofetilCellcept, Myhibbin · 2 products
• CapecitabineXeloda · 2 products
• FinasteridePropecia, Proscar · 2 products
• AllopurinolAloprim · 2 products
• ParicalcitolZemplar · 2 products
• PirfenidoneEsbriet · 2 products
• Carbidopa and levodopaCrexont, Rytary, Sinemet · 2 products
• EplerenoneInspra · 2 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 products
• Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 2 products
• Mycophenolic acidMyfortic · 2 products
• MethotrexateRasuvo, Otrexup, Trexall · 2 products
• SugammadexBridion · 2 products
• ClozapineClozaril, Versacloz · 2 products
• DaptomycinDapzura Rt · 2 products
• Dimethyl fumarateTecfidera · 2 products
• Bendamustine hydrochlorideTreanda, Vivimusta, Belrapzo · 2 products
• TeriflunomideAubagio · 2 products
• PrasugrelEffient · 2 products
• TopotecanHycamtin · 2 products
• BicalutamideCasodex · 1 product
• Zoledronic acidReclast · 1 product
• BusulfanMyleran · 1 product
• FulvestrantCligavyx, Faslodex · 1 product
• Argatroban1 product
• AlcoholDehydrated Alcohol · 1 product
• DalfampridineAmpyra · 1 product
• Oxaliplatin1 product
• Ondansetron1 product
• FingolimodGilenya · 1 product
• EzetimibeZetia · 1 product
• Cisplatin1 product
• Clomiphene citrateClomid, Milophene · 1 product
• EtoposideVepesid, Avopef, Etopophos · 1 product
• MontelukastSingulair · 1 product
• Decitabine1 product
• Bivalirudin1 product
• Acetazolamide1 product
• LetrozoleFemara · 1 product
• AnastrozoleArimidex · 1 product
• DexmedetomidinePrecedex, Dexmedetomidine in Dextrose, Igalmi · 1 product
• DocetaxelBeizray, Docivyx · 1 product
• CarboplatinKyxata · 1 product
• Naltrexone hydrochloride1 product
• AzacitidineOnureg, Vidaza · 1 product
• RegadenosonLexiscan · 1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2026

1. August 6, 2026 · Class II · Ongoing · D-0775-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu

2. August 6, 2026 · Class II · Ongoing · D-0776-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun

3. August 6, 2026 · Class II · Ongoing · D-0783-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu

4. August 6, 2026 · Class II · Ongoing · D-0782-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, M

5. August 6, 2026 · Class II · Ongoing · D-0781-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad

6. August 6, 2026 · Class II · Ongoing · D-0777-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu

7. August 6, 2026 · Class II · Ongoing · D-0784-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 276

8. August 6, 2026 · Class II · Ongoing · D-0785-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617,

9. August 6, 2026 · Class II · Ongoing · D-0780-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad

10. August 6, 2026 · Class II · Ongoing · D-0779-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617

11. August 6, 2026 · Class II · Ongoing · D-0786-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-2

12. August 6, 2026 · Class II · Ongoing · D-0778-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu

13. June 8, 2026 · Class II · Ongoing · D-0656-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-

2025

1. September 16, 2025 · Class II · Ongoing · D-0006-2026 · Levothyroxine

   Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

   Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehra

2. June 20, 2025 · Class II · Ongoing · D-0522-2025 · Levothyroxine

   Subpotent Drug: Assay below the approved specification

   Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu

3. June 20, 2025 · Class II · Ongoing · D-0524-2025 · Levothyroxine

   Subpotent Drug: Assay below the approved specification

   Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu

4. June 20, 2025 · Class II · Ongoing · D-0521-2025 · Levothyroxine

   Subpotent Drug: Assay below the approved specification

   Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-

5. June 20, 2025 · Class II · Ongoing · D-0523-2025 · Levothyroxine

   Subpotent Drug: Assay below the approved specification

   Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun

6. June 20, 2025 · Class II · Ongoing · D-0518-2025 · Levothyroxine

   Subpotent Drug: Assay below the approved specification

   Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-2

7. June 20, 2025 · Class II · Ongoing · D-0520-2025 · Levothyroxine

   Subpotent Drug: Assay below the approved specification

   Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-24

8. June 20, 2025 · Class II · Ongoing · D-0519-2025 · Levothyroxine

   Subpotent Drug: Assay below the approved specification

   Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun

9. April 10, 2025 · Class II · Ongoing · D-0394-2025 · Levothyroxine

   Subpotent

   Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 1

10. April 10, 2025 · Class II · Ongoing · D-0396-2025 · Levothyroxine

    Subpotent

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 1

11. April 10, 2025 · Class II · Ongoing · D-0397-2025 · Levothyroxine

    Subpotent

    Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 19

12. April 10, 2025 · Class II · Ongoing · D-0395-2025 · Levothyroxine

    Subpotent

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 19

2024

1. November 8, 2024 · Class II · Terminated · D-0076-2025 · Levothyroxine

   Subpotent drug

   Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-

2. October 10, 2024 · Class II · Terminated · D-0032-2025 · Cinacalcet

   CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

   Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceut

3. October 10, 2024 · Class II · Terminated · D-0030-2025 · Cinacalcet

   CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

   Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuti

4. October 10, 2024 · Class II · Terminated · D-0031-2025 · Cinacalcet

   CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

   Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceut

5. October 1, 2024 · Class II · Terminated · D-0010-2025 · Cisplatin

   Failed Impurities/Degradation Specifications.

   Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahm

2023

1. July 3, 2023 · Class II · Terminated · D-0918-2023 · Bivalirudin

   Presence of Particulate Matter: Particulate matter identified as fiber.

   Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.

2. July 3, 2023 · Class II · Terminated · D-0917-2023 · Atropine

   Presence of Particulate Matter: Particulate matter identified as fiber.

   Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382

3. February 7, 2023 · Class II · Terminated · D-0400-2023 · Montelukast

   CGMP Deviations: recalling drug products following an FDA inspection.

   Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3

4. February 7, 2023 · Class II · Terminated · D-0387-2023 · Doxazosin

   CGMP Deviations: recalling drug products following an FDA inspection.

   Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 2770

5. February 7, 2023 · Class II · Terminated · D-0386-2023 · Doxazosin

   CGMP Deviations: recalling drug products following an FDA inspection.

   Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; Manufactured for: Accord Healthcare, Inc., Durham, N

6. February 7, 2023 · Class II · Terminated · D-0389-2023 · Doxazosin

   CGMP Deviations: recalling drug products following an FDA inspection.

   Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.

7. February 7, 2023 · Class II · Terminated · D-0430-2023 · Ropinirole

   CGMP Deviations: recalling drug products following an FDA inspection.

   rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC

8. February 7, 2023 · Class II · Terminated · D-0425-2023 · Ropinirole

   CGMP Deviations: recalling drug products following an FDA inspection.

   rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01,

9. February 7, 2023 · Class II · Terminated · D-0431-2023 · Ropinirole

   CGMP Deviations: recalling drug products following an FDA inspection.

   rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC

10. February 7, 2023 · Class II · Terminated · D-0429-2023 · Ropinirole

    CGMP Deviations: recalling drug products following an FDA inspection.

    rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC

11. February 7, 2023 · Class II · Terminated · D-0388-2023 · Doxazosin

    CGMP Deviations: recalling drug products following an FDA inspection.

    Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16729-213-17 UPC 3 16729 21317 2; Manufactured for: Accord Healthcare, Inc., Durham,

12. February 7, 2023 · Class II · Terminated · D-0428-2023 · Ropinirole

    CGMP Deviations: recalling drug products following an FDA inspection.

    rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC

13. February 7, 2023 · Class II · Terminated · D-0427-2023 · Ropinirole

    CGMP Deviations: recalling drug products following an FDA inspection.

    rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC

14. February 7, 2023 · Class II · Terminated · D-0426-2023 · Ropinirole

    CGMP Deviations: recalling drug products following an FDA inspection.

    rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, U

15. February 7, 2023 · Class II · Terminated · D-0390-2023 · Finasteride

    CGMP Deviations: recalling drug products following an FDA inspection.

    Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 9; Manufactured for: Accord Healthcare, Inc., Durham, NC

16. February 7, 2023 · Class II · Terminated · D-0371-2023 · Atorvastatin

    CGMP Deviations: recalling drug products following an FDA inspection.

    Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham,

17. February 7, 2023 · Class II · Terminated · D-0424-2023 · Pravastatin sodium

    CGMP Deviations: recalling drug products following an FDA inspection.

    Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-0

18. February 7, 2023 · Class II · Terminated · D-0406-2023 · Rosuvastatin

    CGMP Deviations: recalling drug products following an FDA inspection.

    Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Du

19. February 7, 2023 · Class II · Terminated · D-0375-2023 · Buspirone

    CGMP Deviations: recalling drug products following an FDA inspection.

    BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16

20. February 7, 2023 · Class II · Terminated · D-0385-2023 · Dofetilide

    CGMP Deviations: recalling drug products following an FDA inspection.

    Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492

21. February 7, 2023 · Class II · Terminated · D-0373-2023 · Atorvastatin

    CGMP Deviations: recalling drug products following an FDA inspection.

    Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, N

22. February 7, 2023 · Class II · Terminated · D-0398-2023 · Glycopyrrolate

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ph

23. February 7, 2023 · Class II · Terminated · D-0378-2023 · Buspirone

    CGMP Deviations: recalling drug products following an FDA inspection.

    BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 167

24. February 7, 2023 · Class II · Terminated · D-0404-2023 · Rosuvastatin

    CGMP Deviations: recalling drug products following an FDA inspection.

    Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc.,

25. February 7, 2023 · Class II · Terminated · D-0370-2023 · Aripiprazole

    CGMP Deviations: recalling drug products following an FDA inspection.

    Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-01, UPC 3 16729 28301 4; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.

26. February 7, 2023 · Class II · Terminated · D-0420-2023 · Pirfenidone

    CGMP Deviations: recalling drug products following an FDA inspection.

    Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3

27. February 7, 2023 · Class II · Terminated · D-0393-2023 · Glimepiride

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham,

28. February 7, 2023 · Class II · Terminated · D-0382-2023 · Daptomycin

    CGMP Deviations: recalling drug products following an FDA inspection.

    Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5.

29. February 7, 2023 · Class II · Terminated · D-0412-2023 · Simvastatin

    CGMP Deviations: recalling drug products following an FDA inspection.

    Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham

30. February 7, 2023 · Class II · Terminated · D-0394-2023 · Glimepiride

    CGMP Deviations: recalling drug products following an FDA inspection.

    Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703.

Showing the newest 60 of 95.

1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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