Why it was recalled
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Product description
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
Lot numbers, UPCs & expiration codes
Lot #: a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.
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-0137-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 27, 2016
- FDA report date
- Nov 23, 2016
- Quantity
- a) 15,409 bottles b) 5,128 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-0137-2017, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 75581
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.
- Postal code
- 43217-1188
- Report date
- Nov 23, 2016
- Product type
- Drugs
- Recall number
- D-0137-2017
- Classification
- Class III
- Recalling firm
- Amerisource Health Services
- Product quantity
- a) 15,409 bottles b) 5,128 bottles
- Termination date
- Jun 29, 2017
- Reason for recall
- Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 16, 2016