Drug product
MethylPREDNISolone (100 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3115-07
D-0265-2016
Product summary
- Event
- Event 72179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,629 vials
- Official record key
drug-enforcement:D-0265-2016
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@41 BUD: 12/5/2015, 20151205@67 BUD: 11/8/2015, 20151504@24 BUD: 10/12/2015, 20152306@30 BUD: 12/20/2015, 20152603@27 BUD: 9/22/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility