Drug product
MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and Distributed by: American Health Packaging, Columbus, OH ---- Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11
D-0043-2015
Product summary
- Event
- Event 69511
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,005 cartons
- Official record key
drug-enforcement:D-0043-2015
Official wording
Reason: Subpotent; 6 month stability time point
Code information: AHP Lot #: 134124 and 140364 Expiration Date of both lots: 05/2015 Carton NDC #: 68084-149-01 Single Dose NDC #: 68084-149-11
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent