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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 6841–6860 of 17,773 recalls

Class IITerminated

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

AVKARE Inc.

Failed Stability Specifications.

August 28, 2019 · DrugView details →
Class IIITerminated

Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH

American Health Packaging

Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.

August 27, 2019 · DrugView details →
Class IIITerminated

minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.

EPI Health, LLC

Failed Dissolution Specifications:

August 26, 2019 · DrugView details →
Class IITerminated

Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302

Tuscano and Delucia Group (DBA Entropic Labs)

Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)

August 24, 2019 · DrugView details →
Class IITerminated

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IITerminated

Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785.

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

August 23, 2019 · DrugView details →
Class IIITerminated

Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10

Macleods Pharma Usa Inc

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

August 21, 2019 · DrugView details →
Class IITerminated

Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.

SCA Pharmaceuticals, LLC

Lack of Assurance of Sterility.

August 16, 2019 · DrugView details →
Class IITerminated

RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.

Pfizer Inc.

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

August 14, 2019 · DrugView details →
Class IITerminated

S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility

August 12, 2019 · DrugView details →
Class IITerminated

S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compounding Rx.

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility

August 12, 2019 · DrugView details →
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