FDA-Drug2014-11-05Class III
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
Valeant Pharmaceuticals North America LLC
Hazard
Labeling: Incorrect or Missing Package Insert
Sold states
Nationwide
Affected count
55,650 HDPE bottles
Manufactured in
400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2015Don't want to check this manually?
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