The Recall Desk

FDA (Drugs) recall action 82196

Macleods Pharma Usa Inc recalled 3 products on 2019-03-20

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
2019-03-20
Critical
0
Units
368,311

Why these products were recalled

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

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

  • ModerateFDA (Drugs)··2019-03-20

    Macleods Pharma Recalls Telmisartan and Hydrochlorothiazide Tablets for Blend Uniformity

    Macleods Pharma USA is recalling Telmisartan and Hydrochlorothiazide tablets because they failed content uniformity specifications for blend uniformity.

    Product
    Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-03-20

    Macleods Pharma Recalls Telmisartan and Hydrochlorothiazide Tablets for Blend Uniformity

    Macleods Pharma USA is recalling Telmisartan and Hydrochlorothiazide tablets because they failed blend uniformity specifications. The recall covers 140,589 bottles distributed nationwide.

    Product
    Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2019-03-20

    Macleods Pharma Recalls Telmisartan and Hydrochlorothiazide Tablets for Blend Uniformity

    Macleods Pharma USA is recalling Telmisartan and Hydrochlorothiazide tablets because they failed blend uniformity specifications.

    Product
    Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07
    Category
    Distribution
    0 states