FDA recall D-090-2013

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.

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.

Distribution

VA

Key facts

Status

Terminated

Initiation date

2011-04-08

Report date

2012-12-19

Termination date

2013-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-090-2013