The Recall Desk

FDA (Drugs) recall action 67664

Teva Pharmaceuticals USA recalled 3 products on 2014-04-09

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
2014-04-09
Critical
0
Units
1,050,266

Why these products were recalled

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

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

1–3 of 3

  • ModerateFDA (Drugs)··2014-04-09

    Teva Recalls Duloxetine Capsules Due to Reported Breakage

    Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx Only, 60 capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2014-04-09

    Teva Recalls Duloxetine Capsules Due to Reported Capsule Breakage

    Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
    Category
    Distribution
    4 states
  • ModerateFDA (Drugs)··2014-04-09

    Teva Recalls Duloxetine Capsules Due to Reported Breakage

    Teva Pharmaceuticals USA is voluntarily recalling specific lots of Duloxetine Delayed-Release Capsules due to a customer complaint trend regarding capsule breakage.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7544-56
    Category
    Distribution
    4 states