Reported Nov 23, 2016 · Terminated
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count…
Amerisource Health Services
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amerisource Health Services · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
- 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 byCadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
- Lot codes and dates
Lot #: a) M601509Exp 3/31/2018M606506Exp 4/30/2018b) M601510Exp 3/31/2018M604444Exp 4/30/2018M606515Exp 4/30/2018
- Amount recalled
- a) 15,409 bottles b) 5,128 bottles
Where it was sold
- Nationwide
- PR
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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