The Recall Desk

FDA (Drugs) recall action 69928

Micro Labs Usa, Inc S recalled 3 products on 2015-03-18

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
2015-03-18
Critical
0
Units
26,952

Why these products were recalled

Failed Impurities/Degradation Specifications: Product failed a known impurity 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.

1–3 of 3

  • ModerateFDA (Drugs)··2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling Simvastatin Tablets, 40mg, because the product failed a known impurity specification. The recall affects 13,488 bottles distributed nationwide.

    Product
    Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling 13,464 bottles of Simvastatin 80mg tablets because the product failed a known impurity specification.

    Product
    Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2015-03-18

    Micro Labs Recalls Simvastatin Tablets Due to Impurity Failure

    Micro Labs USA Inc. is recalling specific lots of Simvastatin Tablets, 20mg, because the product failed a known impurity specification.

    Product
    Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
    Category
    Distribution
    0 states