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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 301–320 of 1,000 recalls

Class IIITerminated

Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

Dr. Reddy's Laboratories, Inc.

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

March 16, 2022 · DrugView details →

Class IIITerminated

Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.

Macleods Pharma Usa Inc

FAILED CONTENT UNIFORMITY SPECIFICATIONS

March 10, 2022 · DrugView details →

Class IIITerminated

Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sub Potent

March 8, 2022 · DrugView details →

Class IIITerminated

T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

Olympia Compounding Pharmacy dba Olympia Pharmacy

Super Potent

March 8, 2022 · DrugView details →

Class IIITerminated

Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sub Potent

March 8, 2022 · DrugView details →

Class IIITerminated

SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sub Potent

March 8, 2022 · DrugView details →

Class IIITerminated

Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07

Fagron, Inc

Subpotent Drug

March 4, 2022 · DrugView details →

Class IIITerminated

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56

Fagron, Inc

Subpotent Drug

March 4, 2022 · DrugView details →

Class IIITerminated

Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04

Fagron, Inc

Subpotent Drug

March 4, 2022 · DrugView details →

Class IIITerminated

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05

Fagron, Inc

Subpotent Drug

March 4, 2022 · DrugView details →

Class IIITerminated

Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43

Fagron, Inc

Subpotent Drug

March 4, 2022 · DrugView details →

Class IIITerminated

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

Taro Pharmaceuticals U.S.A., Inc.

Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample

February 25, 2022 · DrugView details →

Class IIITerminated

Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).

Dr. Reddy's Laboratories, Inc.

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

February 17, 2022 · DrugView details →

Class IIITerminated

Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Subpotent drug

February 14, 2022 · DrugView details →

Class IIITerminated

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62

Dr. Reddy's Laboratories, Inc.

Failed stability specifications

January 19, 2022 · DrugView details →

Class IIITerminated

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

Dr. Reddy's Laboratories, Inc.

Failed stability specifications

January 19, 2022 · DrugView details →

Class IIITerminated

Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60

Dr. Reddy's Laboratories, Inc.

Failed stability specifications

January 19, 2022 · DrugView details →

Class IIITerminated

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made in India, NDC 0363-164-3

Dr. Reddy's Laboratories, Inc.

Subpotent drug

January 10, 2022 · DrugView details →

Class IIITerminated

Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42

Teva Pharmaceuticals USA

Mislabeling

January 7, 2022 · DrugView details →

Class IIITerminated

Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28

Teva Pharmaceuticals USA

Mislabeling

January 7, 2022 · DrugView details →

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