The Recall Desk

FDA (Drugs) recall action 62924

Physicians Total Care, Inc. recalled 3 products on 2012-12-19

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
2012-12-19
Critical
0
Units
19

Why these products were recalled

Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.

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)··2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling 5 bottles of Enjuvia tablets due to low assay results. The medication was distributed in Virginia.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling Enjuvia tablets due to low assay results. The recall is limited to a specific lot and expiration date.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-12-19

    Physicians Total Care Recalls Subpotent Enjuvia Tablets

    Physicians Total Care is recalling specific lots of Enjuvia tablets because they failed potency tests. The affected medication may contain less active ingredient than labeled.

    Product
    Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
    Category
    Distribution
    1 state