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
- Recalling Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- 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.
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