The Recall Desk

FDA (Drugs) recall action 67784

Caraco Pharmaceutical Laboratories, Ltd. recalled 2 products on 2014-05-07

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
2014-05-07
Critical
0
Units
251,882

Why these products were recalled

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

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

1–2 of 2

  • ModerateFDA (Drugs)··2014-05-07

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Caraco Pharmaceutical Laboratories is recalling 160,105 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug release dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah…
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-05-07

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failure

    Caraco Pharmaceutical Laboratories is recalling 91,777 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, because stability results showed the product did not meet drug release dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah…
    Category
    Distribution
    1 state