Status
Terminated
Drug Enforcement D-0096-2023
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Classification
Class III
Report Date
January 11, 2023
Termination Date
December 5, 2023
Product Information
- Product description
- Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
- Product quantity
- 14,061 bottles
- Reason for recall
- Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Address
-
207 Kiley Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0096-2023
- Event ID
- 91412
- Recall initiation date
- December 27, 2022
- Center classification date
- January 5, 2023
- Code info
- Lot#: 21P0336, Exp: 04/2023
- More code info
- —