Why it was recalled
Failed Dissolution Specifications
Product description
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
Lot numbers, UPCs & expiration codes
Lot HAD0630A, exp 1/2024
Where it was sold
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-0137-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 22, 2023
- FDA report date
- Dec 13, 2023
- Quantity
- 2016 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0137-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 93472
- Address
- 2 Independence Way
- Code information
- Lot HAD0630A, exp 1/2024
- Postal code
- 08540-6620
- Report date
- Dec 13, 2023
- Product type
- Drugs
- Recall number
- D-0137-2024
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 2016 Bottles
- Termination date
- Jun 27, 2024
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 1, 2023