Recalls / Class II
Class IID-0899-2022
Product
RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Affected lot / code info
- Lots: K24B09, K24C09 BUD: 11/09/2022
Why it was recalled
Lack of assurance of sterility.
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
- 1710 vials
- Distribution pattern
- Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Timeline
- Recall initiated
- 2022-05-09
- FDA classified
- 2022-05-25
- Posted by FDA
- 2022-06-01
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0899-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.