PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: December 19, 2012 Initiated: April 8, 2011 #D-092-2013

Product Description

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.

Reason for Recall

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

Details

Units Affected
5 Bottles
Distribution
VA
Location
Tulsa, OK

Frequently Asked Questions

What product was recalled?
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.. Recalled by Physicians Total Care, Inc.. Units affected: 5 Bottles.
Why was this product recalled?
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 19, 2012. Severity: Low. Recall number: D-092-2013.