Drug product
Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
D-0674-2017
Product summary
- Firm
- InnovaGel
- Event
- Event 76933
- Status
- Terminated
- Classification
- Class III
- Quantity
- Approximately 7,920,177 capsules
- Official record key
drug-enforcement:D-0674-2017
Official wording
Reason: Subpotent
Code information: Batch #: 1404811, 1409802, 1502817, 1504808, 1509810, 1511802, 1603801, Exp. 12/12/2018.
Distribution pattern: NY only
Derived failure modes
-
Potency or specification failure
Subpotent