Reported Nov 5, 2014 · Terminated
APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), 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
Is this the product you have?
- 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
- Lot codes and dates
Lot #: a) 13E020PExp. 03/17 Lot #: b) 13E029P13E028P13K032PExp. 03/17
- Amount recalled
- 23,057 HDPE bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or Missing Package Insert
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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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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