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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 5581–5600 of 8,801 recalls

Class IIITerminated

DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10

Golden State Medical Supply Inc.

Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018

June 28, 2016 · DrugView details →

Class IIITerminated

Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512

Sun Pharmaceutical Industries, Inc.

Failed Impurities/Degradation Specifications

June 27, 2016 · DrugView details →

Class IITerminated

Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

Teva North America

Superpotent drug: Out of specification test result for assay during stability testing.

June 24, 2016 · DrugView details →

Class IITerminated

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

Hospira Inc.

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

June 23, 2016 · DrugView details →

Class IITerminated

Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16

Teva North America

Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.

June 22, 2016 · DrugView details →

Class IITerminated

Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91

Mylan Pharmaceuticals Inc.

Failed Dissolution Specifications

June 22, 2016 · DrugView details →

Class IITerminated

Calcium Gluconate 2.5% -- 20 mL PLASTIC SYRINGE, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

W & C dba The Apothecary

Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.

June 20, 2016 · DrugView details →

Class IITerminated

Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin 25 mcg -- 4.2 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

W & C dba The Apothecary

Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.

June 20, 2016 · DrugView details →

Class IITerminated

Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377

W & C dba The Apothecary

Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.

June 20, 2016 · DrugView details →

Class IITerminated

Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)

Teva North America

CGMP Deviations

June 17, 2016 · DrugView details →

Class IITerminated

Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)

Teva North America

CGMP Deviations

June 17, 2016 · DrugView details →

Class IIITerminated

Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.

Jubilant Cadista Pharmaceuticals, Inc.

Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.

June 13, 2016 · DrugView details →

Class IITerminated

Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, Nonpyrogenic, Preservative-free, Rx Only, Mfd for Sagent Pharmaceuticals, Schaumberg, IL, 60196, USA, Made in India, NDC 25021-163-69

Sagent Pharmaceuticals Inc

Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.

June 13, 2016 · DrugView details →

Class IIITerminated

SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.

Valeant Pharmaceuticals North America LLC

Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.

June 10, 2016 · DrugView details →

Class IIITerminated

Urea (50% Urea in a Cream Base), a) Net Wt. 5 oz (142 g), (NDC 42808-0200-05) b) Net Wt. 9 oz (225 g) (NDC 42808-0200-09), Rx Only, Manufactured in the U.S.A. for Exact-Rx Inc., Melville, NY

Exact-Rx Inc

Crystallization; complaints received by the manufacturer of crystals forming in product

June 2, 2016 · DrugView details →

Class IIITerminated

Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01

Aidarex Pharmaceuticals LLC

Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

June 1, 2016 · DrugView details →

Class IITerminated

CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.

Aidarex Pharmaceuticals LLC

Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

June 1, 2016 · DrugView details →

Class IIITerminated

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.

Teva North America

Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.

May 31, 2016 · DrugView details →

Class IIITerminated

Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11

Par Pharmaceutical

Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.

May 28, 2016 · DrugView details →

Class IIITerminated

Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5), Distributed by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC

Taro Pharmaceuticals U.S.A., Inc.

Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.

May 26, 2016 · DrugView details →

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