Reported Aug 26, 2015 · Terminated
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed…
Sun Pharma Global Fze
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 Pharma Global Fze · Office # 43 Block Y Saif Zone · Sharm · N/A
Is this the product you have?
- buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle
- Distributed bySun Pharmaceutical Industries Inc. Cranbury, NJ 08512
- Manufactured BySun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
- Lot codes and dates
Lot #s: JKM4152AJKM4737AJKM5270AExp 08/2015
- Amount recalled
- 35,235 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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