Valeant Pharmaceuticals North America LLC recalls APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-c
Recalled November 5, 2014 · FDA recall D-0053-2015 · Valeant Pharmaceuticals North America
Hazard
Labeling: Incorrect or Missing Package Insert · FDA Class III
Units
55,650 HDPE bottles
Sold at
Nationwide
Description
Labeling: Incorrect or Missing Package Insert
Product
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (NDC 0024-5812-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
Manufacturer(s)
Valeant Pharmaceuticals North America LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →