Hospira, Inc.

• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 3 products
• CeftazidimeTazicef · 3 products
• Cisatracurium besylate3 products
• Milrinone lactateMilrinone Lactate in Dextrose · 3 products
• MetoprololToprol XL, Lopressor, Kapspargo · 2 products
• Ampicillin sodium and sulbactam sodiumUnasyn · 2 products
• PhytonadioneVitamin K1 · 2 products
• Chromic chlorideChromium · 2 products
• MetoclopramideReglan, Gimoti · 2 products
• Aminophylline2 products
• Testosterone cypionateDepo-Testosterone, Azmiro · 2 products
• DaptomycinDapzura Rt · 2 products
• Atracurium besylate2 products
• AztreonamAzactam · 2 products
• LevetiracetamKeppra, Spritam, Keppra XR · 2 products
• LabetalolLabetalol HCL in Dextrose · 2 products
• CefepimeCefepime Hydrochloride and Dextrose · 2 products
• Vincristine sulfate2 products
• Butorphanol tartrate2 products
• AcetylcysteineAcetadote · 2 products
• HetastarchHextend · 2 products
• AtropineAtropen Auto-Injector, Isopto Atropine · 2 products
• DiazepamValium, Valtoco · 2 products
• FentanylFentanyl System · 2 products
• PaclitaxelPaclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), Paclitaxel 100mg Per Vial, Abraxane · 2 products
• Norepinephrine bitartrateLevophed · 2 products
• CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 2 products
• FluconazoleDiflucan · 2 products
• FurosemideLasix, Furoscix, Lasix Onyu · 2 products
• Dextran 40Lmd in Dextrose, Lmd in Sodium Chloride · 2 products
• Ketamine hydrochlorideKetalar · 2 products
• Gentamicin sulfateGentak · 1 product
• Mitoxantrone1 product
• Ertapenem sodiumInvanz · 1 product
• Manganese chloride1 product
• Sodium chloride, calcium chloride, potassium chloride, magnesium chloride, and sodium acetate anhydrousTpn Electrolytes · 1 product
• Erythromycin lactobionateErythrocin Lactobionate · 1 product
• Potassium phosphatesPotassium Phosphates · 1 product
• BusulfanMyleran · 1 product
• Calcium chloride1 product
• Carboprost tromethamineHemabate · 1 product
• Potassium chloride, sodium chloride, calcium chloride, and magnesium chloridePlegisol, Cardioplegic Solution, Cardioplegic · 1 product
• Procainamide hydrochloride1 product
• Zinc chloride1 product
• LinezolidZyvox · 1 product
• TromethamineTham · 1 product
• MannitolOsmitrol · 1 product
• Cupric chlorideCopper · 1 product
• MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 1 product
• BuprenorphineBelbuca, Brixadi, Buprenorphine Transdermal System · 1 product
• Aminocaproic acid1 product
• SuccinylcholineAnectine, Quelicin · 1 product
• PentostatinNipent · 1 product
• Deferoxamine mesylateDesferal · 1 product
• DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 1 product
• Irinotecan hydrochlorideCamptosar, Onivyde · 1 product
• Oxaliplatin1 product
• TopotecanHycamtin · 1 product
• Regadenoson (regadenoson anhydrous)1 product
• LorazepamAtivan, Loreev XR · 1 product
• Sufentanil citrate1 product
• TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
• EtomidateAmidate · 1 product
• Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrousSodium Phosphates · 1 product

2022

1. September 27, 2022 · Class II · Terminated · D-0003-2023 · Aminophylline

   Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.

   Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)

2. August 22, 2022 · Class I · Terminated · D-1540-2022 · Propofol

   Presence of particulate matter

   PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake

3. July 13, 2022 · Class I · Terminated · D-1301-2022 · Propofol

   Presence of particulate matter: particulate identified as a beetle.

   Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc.,

4. April 13, 2022 · Class II · Terminated · D-1095-2022 · Bupivacaine hydrochloride and epinephrine bitartrate, Bupivacaine hydrochloride

   cGMP deviations: Temperature abuse

   Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

2021

1. November 30, 2021 · Class II · Terminated · D-0265-2022 · Dextrose monohydrate

   Lack of sterility assurance: bag has the potential to leak.

   5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66

2. May 3, 2021 · Class II · Terminated · D-0384-2021 · Water

   Presence of Particulate Matter: particulate matter identified as an insect in one vial.

   Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25

3. May 3, 2021 · Class I · Terminated · D-0626-2021 · Bupivacaine hydrochloride and epinephrine bitartrate, Bupivacaine hydrochloride

   Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

   0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake For

4. May 3, 2021 · Class I · Terminated · D-0627-2021 · Lidocaine

   Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

   1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

5. March 15, 2021 · Class II · Terminated · D-0553-2021 · Methotrexate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38.

2020

1. July 20, 2020 · Class II · Terminated · D-1446-2020 · Fentanyl

   Lack of Assurance of Sterility; potential loose metal overseal crimp defects.

   Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12

2019

1. November 27, 2019 · Class II · Terminated · D-0577-2020 · Dextrose monohydrate

   Labeling: Incorrect or Missing Lot and/or expiration date.

   25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10

2. 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

3. October 2, 2019 · Class II · Terminated · D-0136-2020 · Dextran 40

   Lack of Assurance of Sterility: Bag has the potential to leak.

   10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13

4. September 6, 2019 · Class II · Terminated · D-1852-2019 · Water

   Lack of Assurance of Sterility

   Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03

5. 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

6. March 15, 2019 · Class I · Terminated · D-1073-2019 · Sodium bicarbonate

   Presence of Particulate Matter; glass particulates

   8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02

2018

1. October 3, 2018 · Class II · Terminated · D-0015-2019 · Magnesium sulfate heptahydrate

   Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.

   Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.

2. June 4, 2018 · Class I · Terminated · D-0906-2018 · Naloxone hydrochloride

   Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

   Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL

3. February 20, 2018 · Class II · Terminated · D-0576-2018 · Labetalol

   Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

   Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake F

4. February 7, 2018 · Class I · Terminated · D-0597-2018 · Hydromorphone hydrochloride

   Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.

   Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01

2017

1. August 30, 2017 · Class I · Terminated · D-0123-2018 · Vancomycin

   Presence of Particulate Matter: glass particulate found in vial

   Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02

2. August 22, 2017 · Class II · Terminated · D-1168-2017 · Norepinephrine bitartrate

   Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

   Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3375-04

3. August 22, 2017 · Class II · Terminated · D-1167-2017 · Hydromorphone hydrochloride

   Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

   HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)

4. July 26, 2017 · Class II · Terminated · D-1081-2017 · Hydromorphone hydrochloride

   Presence of Particulate Matter: Silicone oil

   Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc., Lake Forest, IL 60045 USA, NDC: 0409-2634-50

5. June 15, 2017 · Class II · Terminated · D-1047-2017 · Sodium bicarbonate

   Lack of Sterility Assurance

   8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02

6. June 15, 2017 · Class II · Terminated · D-1048-2017 · Succinylcholine

   Lack of Sterility Assurance

   Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).

7. May 18, 2017 · Class II · Terminated · D-0898-2017 · Norepinephrine bitartrate

   GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

   Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04

8. April 21, 2017 · Class I · Ongoing · D-0862-2017 · Dextrose monohydrate

   Presence of Particulate Matter: human hair found within an internal sample syringe.

   Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10

2016

1. November 1, 2016 · Class II · Terminated · D-0153-2017 · Chromic chloride

   Lack of Assurance of Sterility: Complaints of broken tips on the ampules.

   Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32

2. October 19, 2016 · Class III · Terminated · D-0145-2017 · Ceftriaxone sodium

   Labeling: Missing Label

   Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01

3. August 4, 2016 · Class I · Ongoing · D-0218-2017 · Bupivacaine hydrochloride and epinephrine bitartrate, Bupivacaine hydrochloride

   Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

   Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02

4. June 23, 2016 · Class II · Terminated · D-1359-2016 · Diazepam

   Crystallization: Product contains particulate identified to be crystallized active ingredient.

   Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32

5. March 23, 2016 · Class I · Ongoing · D-1137-2016 · Magnesium sulfate heptahydrate

   Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

   Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 21

6. March 23, 2016 · Class III · Ongoing · D-0854-2016 · Magnesium sulfate heptahydrate

   Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

   Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 21

7. March 18, 2016 · Class I · Ongoing · D-0865-2016 · Sodium bicarbonate

   Presence of Particulate Matter: particulate matter identified as an insect in one vial.

   8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02

8. March 15, 2016 · Class III · Ongoing · D-0836-2016 · Succinylcholine

   Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

   Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

9. January 5, 2016 · Class I · Terminated · D-0668-2016 · Magnesium sulfate heptahydrate

   Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.

   Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.

2015

1. August 25, 2015 · Class II · Ongoing · D-1815-2015 · Lidocaine

   Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

   1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02

2. June 30, 2015 · Class II · Ongoing · D-1242-2015 · Ketorolac tromethamine

   Crystallization; identified as calcium salt of Ketorolac

   KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

3. June 30, 2015 · Class II · Ongoing · D-1241-2015 · Ketorolac tromethamine

   Crystallization; identified as calcium salt of Ketorolac

   KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

4. May 19, 2015 · Class III · Terminated · D-1232-2015 · Magnesium sulfate heptahydrate

   Failed pH Specifications: 12 month stability testing

   Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, I

5. April 23, 2015 · Class I · Terminated · D-1216-2015 · Bupivacaine hydrochloride and epinephrine bitartrate, Bupivacaine hydrochloride

   Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

   Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

6. April 7, 2015 · Class II · Terminated · D-0490-2015 · Sodium chloride

   Lack of Sterility Assurance: The product has the potential to leak at the administrative port.

   0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67

7. March 6, 2015 · Class I · Terminated · D-1076-2015 · Magnesium sulfate heptahydrate

   Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

   MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.

8. March 5, 2015 · Class II · Terminated · D-0417-2015 · Dextrose monohydrate

   Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

   5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Fores

9. January 23, 2015 · Class II · Terminated · D-0482-2015 · Ketorolac tromethamine

   Crystallization

   KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49

10. January 23, 2015 · Class II · Terminated · D-0483-2015 · Ketorolac tromethamine

    Crystallization

    KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49

2014

1. December 23, 2014 · Class II · Terminated · D-0381-2015 · Propofol

   Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

   Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

2. December 3, 2014 · Class I · Terminated · D-0433-2015 · Mitoxantrone

   Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.

   MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 6

3. December 3, 2014 · Class II · Terminated · D-0294-2015 · Fentanyl

   Lack of Assurance of Sterility; improperly crimped fliptop vials

   Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

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).