Class III
Terminated
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
This recall has been terminated (originally issued November 5, 2014).
- Recall Initiated
- June 5, 2014
- Posted
- November 5, 2014
- Recall Number
- D-0053-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 55,650 HDPE bottles
- Firm Location
- Bridgewater, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Distribution
Nationwide
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
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