Why it was recalled
Failed Dissolution Specifications; 6 month time point
Product description
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Lot numbers, UPCs & expiration codes
a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018
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-0207-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 2, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 16,356 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0207-2017, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75764
- Address
- 73 Route 31 N
- Code information
- a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018
- Postal code
- 08534-3601
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0207-2017
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 16,356 bottles
- Termination date
- Jul 23, 2020
- Reason for recall
- Failed Dissolution Specifications; 6 month time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 2, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2016