Reported Dec 28, 2016 · Terminated
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b)…
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 (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05)
- Manufactured byCadila Healthcare LTD. Ahmedabad
- India Distributed byZydus Pharmaceuticals USA Inc. Pennington, NJ 08534
- Lot codes and dates
a) MS1667 exp 01/2018M601708exp 03/2018b) MS1667MS1668MS1669exp 01/2018M601515M601516exp 03/2018M602920M602921M605399M602937M602938M602939exp 04/2018M603988exp 06/2018
- Amount recalled
- 16,356 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications; 6 month time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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