D-0825-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- April 4, 2022
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1276 vials
Product Description
Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10.
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
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lots: E48020 BUD: 5/20/2022 and G47006 BUD: 7/6/2022