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
Reported: November 5, 2014 Initiated: June 5, 2014 #D-0053-2015
Product Description
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
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Details
- Recalling Firm
- Valeant Pharmaceuticals North America LLC
- Units Affected
- 55,650 HDPE bottles
- Distribution
- Nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Valeant Pharmaceuticals North America LLC. Units affected: 55,650 HDPE bottles.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 5, 2014. Severity: Low. Recall number: D-0053-2015.
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