Why it was recalled
Failed Tablet/Capsule Specification
Product description
clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
Lot numbers, UPCs & expiration codes
Lot# 20P0141, exp. date 02/2022
Where it was sold
Product was distributed nationwide.
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-0104-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 6, 2020
- FDA report date
- Dec 2, 2020
- Quantity
- 4,416 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0104-2021, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 86698
- Address
- 207 Kiley Dr
- Code information
- Lot# 20P0141, exp. date 02/2022
- Postal code
- 21801-2249
- Report date
- Dec 2, 2020
- Product type
- Drugs
- Recall number
- D-0104-2021
- Classification
- Class II
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 4,416 bottles
- Termination date
- Mar 23, 2022
- Reason for recall
- Failed Tablet/Capsule Specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
- Distribution pattern
- Product was distributed nationwide.
- Recall initiation date
- Nov 6, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 24, 2020