Sun Pharma Global Fze recalls buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed
Recalled August 26, 2015 · FDA recall D-1345-2015 · Sun Pharma Global Fze
Hazard
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. · FDA Class III
Units
35,235 bottles
Sold at
Nationwide and Puerto Rico
Description
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.
Product
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Manufacturer(s)
Sun Pharma Global Fze
Made in
United Arab Emirates
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →