The Recall Desk

FDA (Drugs) recall action 63509

Watson Laboratories Inc recalled 5 products on 2012-10-31

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2012-10-31
Critical
0
Units
118,610

Why these products were recalled

Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

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

1–5 of 5

  • ModerateFDA (Drugs)··2012-10-31

    Watson Recalls Zovia Tablets Due to Potential Cross-Contamination

    Watson Laboratories is recalling Zovia tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ) due to cross-contamination.

    Product
    Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2012-10-31

    Watson Recalls Necon 10/11 Tablets Due to Potential HCTZ Contamination

    Watson Laboratories is recalling specific lots of Necon 10/11 oral contraceptives because they may contain trace amounts of Hydrochlorothiazide (HCTZ).

    Product
    Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson…
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-10-31

    Watson Recalls Zenchent Tablets Due to Potential Hydrochlorothiazide Contamination

    Watson Laboratories is recalling Zenchent tablets because certain lots may be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

    Product
    Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Corona, CA…
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2012-10-31

    Watson Recalls Necon 1/35-28 Tablets Due to Potential Cross-Contamination

    Watson Laboratories is recalling Necon 1/35-28 tablets because certain lots may contain trace amounts of Hydrochlorothiazide (HCTZ). The recall covers 6,466 cartons distributed nationwide and in Puerto Rico.

    Product
    Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880…
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-10-31

    Watson Recalls Lutera Tablets Due to Potential Hydrochlorothiazide Contamination

    Watson Laboratories is recalling specific lots of Lutera tablets because they may contain trace amounts of Hydrochlorothiazide (HCTZ).

    Product
    Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.…
    Category
    Distribution
    1 state