Reported Sep 21, 2016 · Terminated
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila…
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), 300mg, 500-count bottle, Rx only
- Manufactured byCadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
- Lot codes and dates
Lot #: MS1509Exp 12/17
- Amount recalled
- 2626 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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