FDAFDA · Food and drugs·Recall number D-0052-2015
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-count HDPE bottle (NDC 0024-5811-30), Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7
Published November 5, 2014 · Recall initiated: June 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Package Insert
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Valeant Pharmaceuticals North America LLC
- Distributor
- Nationwide
- Lot
- Lot #: a) 13E020P; Exp. 03/17 Lot #: b) 13E029P, 13E028P, 13K032P; Exp. 03/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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