Why it was recalled
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Product description
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Lot numbers, UPCs & expiration codes
Lot#: 21P0336, Exp: 04/2023
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0096-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 27, 2022
- FDA report date
- Jan 11, 2023
- Quantity
- 14,061 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0096-2023, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 91412
- Address
- 207 Kiley Dr
- Code information
- Lot#: 21P0336, Exp: 04/2023
- Postal code
- 21801-2249
- Report date
- Jan 11, 2023
- Product type
- Drugs
- Recall number
- D-0096-2023
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 14,061 bottles
- Termination date
- Dec 5, 2023
- Reason for recall
- Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Dec 27, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2023