The Recall Desk

FDA (Drugs) recall action 71418

Apotex Inc. recalled 4 products on 2015-07-15

The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2015-07-15
Critical
0
Units
96,546

Why these products were recalled

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

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.

States named across these recalls

1–4 of 4

  • ModerateFDA (Drugs)··2015-07-15

    Apotex Recalls Losartan Potassium Tablets for Uniformity Issues

    Apotex Inc. is recalling 23,076 bottles of Losartan potassium tablets 50 mg because the product may not meet blend uniformity specifications.

    Product
    Losartan potassium tablets USP, 50 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3161-9
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2015-07-15

    Apotex Recalls Losartan Potassium Tablets for Blend Uniformity Failure

    Apotex Inc. is recalling Losartan potassium tablets 100 mg because they may not meet blend uniformity specifications. The recall covers 23,178 bottles distributed nationwide, in Hawaii, and Puerto Rico.

    Product
    Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC…
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2015-07-15

    Apotex Recalls Enalapril Maleate and Hydrochlorothiazide Tablets for Uniformity Issues

    Apotex Inc. is recalling 4,584 bottles of Enalapril maleate and hydrochlorothiazide tablets, 10/25 mg, because the product may not meet blend uniformity specifications.

    Product
    Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka…
    Category
    Distribution
    2 states
  • ModerateFDA (Drugs)··2015-07-15

    Apotex Recalls Losartan Potassium Tablets Due to Uniformity Issues

    Apotex Inc. is recalling Losartan potassium tablets 25 mg because they may not meet blend uniformity specifications. The recall covers 45,708 bottles distributed nationwide, in Hawaii, and Puerto Rico.

    Product
    Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC…
    Category
    Distribution
    2 states