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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

cGMP deviations

Apr 25, 2022 Prescription Drugs Nationwide View Details →

QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0020-10.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3

Unilever United States

Class I - Dangerous

CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene

Mar 30, 2022 Other Drugs Nationwide View Details →

Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0055-10; b) 5 mL Multi-Dose vial, NDC 73198-0055-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

RemedyRepack

Class I - Dangerous

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Apr 6, 2022 Prescription Drugs View Details →

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Glenmark Pharmaceuticals Inc., USA

Class I - Dangerous

cGMP deviations

Apr 25, 2022 Prescription Drugs Nationwide View Details →

RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-8347-1, 3780 mL, 3.78 Liters (1 Gallon). Torco Race Fuels 2527 W. Dallas Ave. Apache Junction, AZ, 85120

Torco Race Fuels

Class I - Dangerous

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Apr 21, 2022 Compounded Drugs View Details →

T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00

Olympia Compounding Pharmacy

Class I - Dangerous

Failed Reconstitution time

Apr 4, 2022 Prescription Drugs Nationwide View Details →

SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0025-10.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.

Preferred Pharmaceuticals

Class I - Dangerous

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Apr 12, 2022 Other Drugs Nationwide View Details →

AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →

ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10.

Olympia Compounding Pharmacy

Class I - Dangerous

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Apr 4, 2022 Prescription Drugs Nationwide View Details →