Why it was recalled
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Product description
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Lot numbers, UPCs & expiration codes
Lot #: MR3365, Exp. Feb 17
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-0149-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 3, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- 2,472 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0149-2017, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75696
- Address
- 73 Route 31 N
- Code information
- Lot #: MR3365, Exp. Feb 17
- Postal code
- 08534-3601
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-0149-2017
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 2,472 units
- Termination date
- Jul 12, 2018
- Reason for recall
- Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 3, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 22, 2016