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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 13741–13760 of 17,832 recalls

Class IITerminated

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 Forest, IL 60045.

Hospira Inc.

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

March 5, 2015 · DrugView details →
Class IITerminated

Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.

Safecor Health, LLC

Defective Container: Confirmed customer complaints of leaking bottles.

March 2, 2015 · DrugView details →
Class IITerminated

Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11

American Health Packaging

Failed dissolution specifications

March 2, 2015 · DrugView details →
Class IITerminated

Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinois, 60045. NDC 50383-700-16.

Akorn, Inc.

Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.

February 27, 2015 · DrugView details →
Class IIITerminated

Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15

AVKARE Inc.

Subpotent Drug

February 27, 2015 · DrugView details →
Class IIITerminated

Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15

AVKARE Inc.

Subpotent Drug

February 27, 2015 · DrugView details →
Class IIITerminated

Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01

Pfizer Inc.

Failed Impurities/Degradation Specifications

February 26, 2015 · DrugView details →
Class IIITerminated

Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01

Pfizer Inc.

Failed Impurities/Degradation Specifications

February 26, 2015 · DrugView details →
Class IITerminated

Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31

Heritage Pharmaceuticals, Inc.

Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

February 25, 2015 · DrugView details →
Class IITerminated

RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31

Heritage Pharmaceuticals, Inc.

Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

February 25, 2015 · DrugView details →
Class IITerminated

Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8

Noven Pharmaceuticals, Inc.

Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.

February 25, 2015 · DrugView details →
Class IITerminated

Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16

SCA Pharmaceuticals

Presence of particulate.

February 24, 2015 · DrugView details →
Class IITerminated

Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10

Sagent Pharmaceuticals Inc

Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

February 23, 2015 · DrugView details →
Class IITerminated

Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05

Sagent Pharmaceuticals Inc

Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

February 23, 2015 · DrugView details →
Class IITerminated

PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS: Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%, ONE PINT (574 mL), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-1586-58.

Qualitest Pharmaceuticals

Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.

February 23, 2015 · DrugView details →
Class IITerminated

Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

Mylan Institutional LLC

Lack of Assurance of Sterility; due to leaking vials

February 18, 2015 · DrugView details →
Class IITerminated

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103

Mylan Institutional LLC

Lack of Assurance of Sterility; due to leaking vials

February 18, 2015 · DrugView details →
Class IITerminated

KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01

RemedyRepack Inc.

Crystallization

February 18, 2015 · DrugView details →
Class IIITerminated

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL) 25 x 5 mL Single Dose Vials, For Intravenous or Intramuscular Use, Preservative Free, Rx Only, Manufactured by: West-Ward Pharmaceuticals, Eatontown, NJ 07724, NDC 0641-6028-25.

West-Ward Pharmaceutical Corporation

Failed Impurities/Degradation Specifications; 12 month stability testing.

February 16, 2015 · DrugView details →
Class IITerminated

AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811

Qualitest Pharmaceuticals

Failed tablet specifications: One lot was found to contain oversized tablets.

February 13, 2015 · DrugView details →
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