FDA-Drug2012-12-19Class III

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.

Physicians Total Care, Inc.
Hazard

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

Sold states
VA
Affected count
9 bottles
Manufactured in
12515 E 55th St Ste 100, N/A, Tulsa, OK, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-091-2013

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