FDAClass IIIDecember 19, 2012

Enjuvia recall: Subpotent

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.

Why was Enjuvia recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12

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.
Recalling firm
Physicians Total Care, Inc.
Quantity
9 bottles
Distribution
VA
Recall date
December 19, 2012
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls