FDA Drug recall D-0053-2015
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (N…
- FDA Drug
- Class III
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class III recall of APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-count HDPE bottle (N… by Valeant Pharmaceuticals North America, citing labeling: Incorrect or Missing Package Insert.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0053-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-06-05 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
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
Reason
Labeling: Incorrect or Missing Package Insert
Identifiers
| code_info | Lot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073…Lot #: a) 13E023P; Exp. 03/16 Lot #: b) 12J063P; Exp. 07/15 12K063P; Exp. 09/15 12K060P; Exp. 07/15 12M073P; Exp. 09/15 13A036P; Exp. 11/15 13B035P; Exp. 11/15 13C046P; Exp. 11/15 13D060P; Exp. 11/15 13E030P; Exp. 03/16 13E031P; Exp. 03/16 13F003P; Exp. 03/16 13K034P; Exp. 03/16 14A001P; Exp. 10/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0053-2015%22
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