Reported Nov 5, 2014 · Terminated

APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b)…

Valeant Pharmaceuticals North America LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807

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

Lot codes and dates: 15 of 15 products
Products covered by this recall
# Product as published
1 13E023P
2 Exp. 03/16 Lot #: b) 12J063P
3 Exp. 07/15 12K063P
4 Exp. 09/15 12K060P
5 Exp. 07/15 12M073P
6 Exp. 09/15 13A036P
7 Exp. 11/15 13B035P
8 Exp. 11/15 13C046P
9 Exp. 11/15 13D060P
10 Exp. 11/15 13E030P
11 Exp. 03/16 13E031P
12 Exp. 03/16 13F003P
13 Exp. 03/16 13K034P
14 Exp. 03/16 14A001P
15 Exp. 10/16
Amount recalled: 55,650 HDPE bottles

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Labeling: Incorrect or Missing Package Insert

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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12 in total.