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

FDA recall notice · announced November 23, 2016 · Amerisource Health Services

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide and Puerto Rico
Lot/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.
Quantity: a) 15,409 bottles b) 5,128 bottles
Status: Terminated
Products in this recall event:
- 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, (D-0137-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.