Recalls / Class II
Class IID-0718-2022
Product
Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00
- Affected lot / code info
- Lots: D44026 Exp. 4/26/22; F42104 Exp. 6/4/22
Why it was recalled
Sub Potent
Recalling firm
- Firm
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6700 Conroy Rd Ste 155, N/A, Orlando, Florida 32835-3515
Distribution
- Quantity
- 2283 vials
- Distribution pattern
- Nationwide in the USA including Puerto Rico.
Timeline
- Recall initiated
- 2022-03-08
- FDA classified
- 2022-03-29
- Posted by FDA
- 2022-03-30
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0718-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.