Drug product
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
D-0096-2023
Product summary
- Event
- Event 91412
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14,061 bottles
- Official record key
drug-enforcement:D-0096-2023
Official wording
Reason: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Code information: Lot#: 21P0336, Exp: 04/2023
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Subpotent