The Recall Desk

FDA (Drugs) recall action 67811

Teva Pharmaceuticals USA recalled 4 products on 2014-05-21

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
2014-05-21
Critical
0
Units
38,858

Why these products were recalled

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

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.

1–4 of 4

  • ModerateFDA (Drugs)··2014-05-21

    Teva Recalls Methyldopa Tablets Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is recalling Methyldopa Tablets USP, 500 mg, due to CGMP deviations and laboratory testing not following GMP requirements.

    Product
    METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-05-21

    Teva Recalls Glyburide and Metformin Tablets Due to GMP Deviations

    Teva Pharmaceuticals USA is recalling specific bottles of Glyburide and Metformin Hydrochloride tablets due to laboratory testing deviations from GMP requirements.

    Product
    GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, due to CGMP deviations and laboratory testing failures.

    Product
    INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, because laboratory testing was not conducted in accordance with Good Manufacturing Practice (GMP) requirements.

    Product
    INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
    Category
    Distribution
    0 states