Recalls / Class II
Class IID-0807-2022
Product
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.
- Affected lot / code info
- Lots: E48B18 BUD: 5/18/2022, E48D18 BUD; 5/18/2022, H24D31 BUD: 8/31/2022; E48C18 BUD: 5/18/2022
Why it was recalled
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recalling firm
- Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6700 Conroy Rd Ste 155, Orlando, Florida 32835-3515
Distribution
- Quantity
- 1110 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2022-04-04
- FDA classified
- 2022-04-27
- Posted by FDA
- 2022-05-04
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0807-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.