Why it was recalled
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Product description
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
Lot numbers, UPCs & expiration codes
Lot #: MS1509, Exp 12/17
Where it was sold
Nationwide and Puerto Rico
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-1501-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 4, 2016
- FDA report date
- Sep 21, 2016
- Quantity
- 2626 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-1501-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 75030
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: MS1509, Exp 12/17
- Postal code
- 43217-1188
- Report date
- Sep 21, 2016
- Product type
- Drugs
- Recall number
- D-1501-2016
- Classification
- Class III
- Recalling firm
- Amerisource Health Services
- Product quantity
- 2626 bottles
- Termination date
- Jul 17, 2017
- Reason for recall
- Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Aug 4, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2016