Reported Nov 30, 2016 · Terminated
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila…
Zydus Pharmaceuticals USA Inc.
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: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad
- India Distributed by
Zydus Pharmaceuticals USA inc. PenningtonNJ 08534NDC 68382-354-05
- Lot codes and dates
Lot #: MR3365Exp. Feb 17
- Amount recalled
- 2,472 units
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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