PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: May 4, 2022 Initiated: April 4, 2022 #D-0819-2022

Product Description

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.

Reason for Recall

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

Details

Units Affected
410 vials
Distribution
Distributed Nationwide in the USA
Location
Orlando, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy. Units affected: 410 vials.
Why was this product recalled?
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Which agency issued this recall?
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0819-2022.