The Recall Desk

FDA (Drugs) recall action 68786

Caraco Pharmaceutical Laboratories, Ltd. recalled 2 products on 2014-08-13

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2014-08-13
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

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

States named across these recalls

1–2 of 2

  • ModerateFDA (Drugs)··2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations

    Caraco Pharmaceutical Laboratories is recalling Cephalexin Capsules, 500 mg, because they were manufactured with active pharmaceutical ingredients that did not follow good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-08-13

    Caraco Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Caraco Pharmaceutical is recalling Cephalexin Capsules, 250 mg, because the active ingredients were not manufactured with good manufacturing practices.

    Product
    Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
    Category
    Distribution
    1 state