Drug product
MethylPREDNISolone PF (80 mg/mL), 1 mL Single Use Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3119-01.
D-0266-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,627 vials
- Official record key
drug-enforcement:D-0266-2016
Official wording
Reason: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Code information: Lot Numbers: 20150806@35 BUD: 12/5/2015, 20151006@34 BUD: 12/7/2015, 20152303@42 BUD: 9/19/2015, 20152704@16 BUD: 10/24/2015, 20152906@26 BUD: 12/26/2015, 20153007@19 BUD: 1/26/2016, 20151703@6 BUD: 9/13/2015, 20151806@12 BUD: 12/15/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility