Reported Jul 27, 2016 · Terminated
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical…
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) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
- Manufactured bySun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
- Lot codes and dates
Lot JKN3477Aexp 07/2016
- Amount recalled
- 16,085 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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