Drug product
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
D-1605-2014
Product summary
- Event
- Event 69233
- Status
- Terminated
- Classification
- Class III
- Quantity
- 159,913 tablets
- Official record key
drug-enforcement:D-1605-2014
Official wording
Reason: Subpotent; 6 month stability time point
Code information: 100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent