Recalls / Class III
Class IIID-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.
- Affected lot / code info
- 62QJ, Exp 12/11
Why it was recalled
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Recalling firm
- Firm
- Physicians Total Care, Inc.
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 5 bottles
- Distribution pattern
- VA
Timeline
- Recall initiated
- 2011-04-08
- FDA classified
- 2012-12-11
- Posted by FDA
- 2012-12-19
- Terminated
- 2013-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-090-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.