FDA Recall
Terminated
Historical recordClass II
AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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
by Olympia Compounding Pharmacy dba Olympia Pharmacy
- Reason
- CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
by Teva Pharmaceuticals USA Inc
- Reason
- cGMP Deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
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
by Glenmark Pharmaceuticals Inc., USA
- Reason
- cGMP deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Zonisamide Capsules, USP, 50 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 68462-129-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- cGMP deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
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
by Glenmark Pharmaceuticals Inc., USA
- Reason
- cGMP deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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.
by RemedyRePack Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Published
- May 4, 2022
- Distribution
- Product was distributed to customers in…
View recall →
FDA Recall
Ongoing
Historical recordClass II
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
by Unilever United States Inc.
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 06611
by Unilever United States Inc.
- Reason
- Chemical contamination: presence of benzene
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
artnaturals Hand Sanitizer
by VIRGIN SCENT INC
- Reason
- CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
by VIRGIN SCENT INC
- Reason
- Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.