Recalls / Class III
Class IIID-0096-2023
Product
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
- Brand name
- Prochlorperazine Maleate
- Generic name
- Prochlorperazine Maleate
- Active ingredient
- Prochlorperazine Maleate
- Route
- Oral
- NDCs
- 59746-113, 59746-115
- FDA application
- ANDA040268
- Affected lot / code info
- Lot#: 21P0336, Exp: 04/2023
Why it was recalled
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 14,061 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-12-27
- FDA classified
- 2023-01-05
- Posted by FDA
- 2023-01-11
- Terminated
- 2023-12-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0096-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.