The Recall Desk

FDA (Drugs) recall action 69445

Valeant Pharmaceuticals North America LLC recalled 3 products on 2014-11-05

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2014-11-05
Critical
0
Units
99,206

Why these products were recalled

Labeling: Incorrect or Missing Package Insert

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • LowFDA (Drugs)··2014-11-05

    Valeant Recalls APLENZIN Tablets Due to Missing Package Insert

    Valeant Pharmaceuticals is recalling APLENZIN extended-release tablets because the package insert is incorrect or missing. Consumers should contact their healthcare provider.

    Product
    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
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-11-05

    Valeant Recalls APLENZIN Tablets Due to Missing Package Insert

    Valeant Pharmaceuticals is recalling APLENZIN (bupropion hydrobromide) extended-release tablets because the package insert is incorrect or missing.

    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
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-11-05

    Valeant Recalls APLENZIN Tablets Due to Missing Package Insert

    Valeant Pharmaceuticals is recalling 20,499 bottles of APLENZIN (bupropion hydrobromide) 174 mg tablets because the package insert is incorrect or missing.

    Product
    APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07.
    Category
    Distribution
    0 states