Recalls / Class III

Class IIID-0053-2015

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

Affected lot / code info

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

Why it was recalled

Labeling: Incorrect or Missing Package Insert

Recalling firm

Firm

Valeant Pharmaceuticals North America LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807

Distribution

Quantity

55,650 HDPE bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2014-06-05

FDA classified

2014-10-28

Posted by FDA

2014-11-05

Terminated

2017-07-27

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0053-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.