Reported Feb 1, 2017 · Terminated
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun…
Sun Pharmaceutical Industries, 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: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
- Manufactured bySun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
- Lot codes and dates
- JKP0905A 04/17
- Amount recalled
- 11,618 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications; 18 month stability time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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