AuroMedics Pharma LLC

2024

1. May 22, 2024 · Class III · Ongoing · D-0556-2024 · Eptifibatide

   Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

   Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10

2. February 22, 2024 · Class II · Terminated · D-0385-2024 · Tobramycin

   Failed Stability Specification: Water determination was found not complying with specification.

   Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470

3. February 20, 2024 · Class II · Ongoing · D-0390-2024 · Nicardipine

   Failed Impurities/Degradation Specifications: Out of specification for organic impurities

   Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10

4. February 20, 2024 · Class II · Ongoing · D-0391-2024 · Nicardipine

   Failed Impurities/Degradation Specifications: Out of specification for organic impurities

   Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11

5. February 20, 2024 · Class II · Ongoing · D-0366-2024 · Methylprednisolone acetate

   Failed Dissolution Specifications

   Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01

6. February 15, 2024 · Class I · Ongoing · D-0440-2024 · Methocarbamol

   Presence of Particulate Matter

   Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10

7. February 7, 2024 · Class II · Terminated · D-0371-2024 · Rocuronium bromide

   cGMP Deviations: Products were stored outside the drug label specifications.

   Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10

2023

1. September 28, 2023 · Class II · Ongoing · D-0041-2024 · Triamcinolone acetonide

   Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.

   Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intra

2022

1. December 28, 2022 · Class II · Ongoing · D-0095-2023 · Acyclovir

   Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

   Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

2. September 30, 2022 · Class II · Terminated · D-0020-2023 · Fondaparinux sodium

   Subpotent Drug: Out of specification for assay

   Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC

3. September 26, 2022 · Class II · Completed · D-0013-2023 · Acyclovir

   Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

   Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.

4. September 26, 2022 · Class III · Ongoing · D-1551-2022 · Tranexamic acid

   Presence of Particulate Matter: Piece of metal found in a vial

   Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10

5. April 13, 2022 · Class II · Terminated · D-0998-2022 · Bupivacaine hydrochloride

   cGMP deviations: Temperature abuse

   Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

6. April 13, 2022 · Class II · Terminated · D-1009-2022 · Ampicillin

   cGMP deviations: Temperature abuse

   Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10

7. April 13, 2022 · Class II · Terminated · D-0997-2022 · Azithromycin

   cGMP deviations: Temperature abuse

   Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10

8. April 5, 2022 · Class III · Terminated · D-0766-2022 · Cyanocobalamin

   Subpotent Drug: Out of Specification results for Assay

   Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01.

9. January 26, 2022 · Class I · Terminated · D-0556-2022 · Polymyxin b sulfate

   Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

   Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

2020

1. December 30, 2020 · Class II · Terminated · D-0248-2021 · Acetaminophen

   Discoloration and failed pH specifications

   Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-3

2. February 7, 2020 · Class III · Terminated · D-0853-2020 · Glycopyrrolate

   Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found in investigative samples (retain samples).

   Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC,

2019

1. November 25, 2019 · Class II · Terminated · D-0574-2020 · Vancomycin

   Discoloration: Product complaints of discoloration after reconstitution of vials.

   Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in India for: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-204-20.

2. November 11, 2019 · Class III · Terminated · D-0521-2020 · Amiodarone hydrochloride

   Crystallization: Presence of visible particulate matter.

   Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09

3. November 11, 2019 · Class III · Terminated · D-0520-2020 · Amiodarone hydrochloride

   Crystallization: Presence of visible particulate matter.

   Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-180-03

4. November 11, 2019 · Class III · Terminated · D-0522-2020 · Amiodarone hydrochloride

   Crystallization: Presence of visible particulate matter.

   Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18

5. November 11, 2019 · Class II · Terminated · D-0573-2020 · Bupivacaine hydrochloride, Lidocaine

   Presence of Foreign Substance: Foreign material found inside the vial.

   Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ

6. March 28, 2019 · Class I · Terminated · D-1248-2019 · Betamethasone sodium phosphate and betamethasone acetate, Bupivacaine hydrochloride, Lidocaine

   Presence of Particulate Matter: One vial was found to contain a hair.

   Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05

2018

1. July 2, 2018 · Class I · Terminated · D-1030-2018 · Piperacillin and tazobactam

   Presence of Particulate Matter: identified as glass and silicone material

   Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30

2. May 1, 2018 · Class I · Terminated · D-0926-2018 · Piperacillin and tazobactam

   Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass

   Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30

3. May 1, 2018 · Class I · Terminated · D-0866-2018 · Ampicillin sodium and sulbactam sodium

   Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.

   Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.

4. March 27, 2018 · Class II · Terminated · D-0706-2018 · Levetiracetam

   Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

   Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-247-47.

5. March 27, 2018 · Class II · Terminated · D-0705-2018 · Levetiracetam

   Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

   Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-246-47.

6. March 27, 2018 · Class II · Terminated · D-0707-2018 · Levetiracetam

   Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

   Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only, Distributed By: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47.

7. March 27, 2018 · Class II · Terminated · D-0709-2018 · Levofloxacin

   Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

   Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured f

8. March 27, 2018 · Class II · Terminated · D-0708-2018 · Levofloxacin

   Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

   Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured f

9. March 27, 2018 · Class II · Terminated · D-0704-2018 · Levofloxacin

   Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

   Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured fo

10. March 27, 2018 · Class II · Terminated · D-0703-2018 · Linezolid

    Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

    Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-

11. January 12, 2018 · Class I · Terminated · D-0574-2018 · Levofloxacin

    Presence of Particulate Matter; contains visible particulate matter identified as mold.

    Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma L

12. January 2, 2018 · Class I · Terminated · D-0339-2018 · Ampicillin sodium and sulbactam sodium

    Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.

    Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20

2017

1. December 20, 2017 · Class I · Terminated · D-0337-2018 · Linezolid

   Presence of Particulate Matter; white particulate matter identified as mold was found in one bag

   Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51

2. December 4, 2017 · Class I · Terminated · D-0340-2018 · Pantoprazole sodium

   Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass

   Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00

2016

1. December 16, 2016 · Class III · Terminated · D-0470-2017 · Pantoprazole sodium

   Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.

   Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).