D-0096-2023 Class III Terminated
FDA drug recall D-0096-2023 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on December 27, 2022 and is designated Class III. Reason for recall: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. The recall status is terminated (terminated December 5, 2023). Affected quantity: 14,061 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 11, 2023
- Initiation Date
- December 27, 2022
- Termination Date
- December 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,061 bottles
Product Description
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Reason for Recall
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot#: 21P0336, Exp: 04/2023