The Recall Desk

FDA (Drugs) recall action 80790

Teva Pharmaceuticals USA recalled 7 products on 2018-10-31

The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2018-10-31
Critical
0
Units
130,514

Why these products were recalled

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

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.

1–7 of 7

  • SevereFDA (Drugs)··2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling 3,397 bottles of Metformin Hydrochloride Extended Release Tablets, 500 mg, because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-10-31

    Teva Recalls Paliperidone Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals is recalling 27,816 bottles of Paliperidone Extended Release Tablets 3 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2018-10-31

    Teva Recalls Pioglitazone and Metformin Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Pioglitazone and Metformin tablets because some may lack laser drilling, potentially affecting drug release.

    Product
    PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkwa
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-10-31

    Teva Recalls Fortamet Extended-Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Fortamet (metformin HCl) extended-release tablets because some may lack laser drilling, potentially affecting drug release.

    Product
    Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-10-31

    Teva Recalls Paliperidone Extended Release Tablets Due to Missing Laser Drilling

    Teva Pharmaceuticals USA is recalling 3,785 bottles of Paliperidone Extended Release Tablets 9 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling 82,291 bottles of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
    Category
    Distribution
    0 states