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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 4,061–4,080 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 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 73198-0006-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 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 73198-0019-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0011-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

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.

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC: 73198-0013-10; b) 5 mL Multi-Dose vial, NDC 73198-0013-05; 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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10

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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug 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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug 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
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.