Status
Terminated
Drug Enforcement D-091-2013
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Classification
Class III
Report Date
December 19, 2012
Termination Date
February 22, 2013
Product Information
- Product description
- 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.
- Product quantity
- 9 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- VA
Location & Firm
- Recalling firm
- Physicians Total Care, Inc.
- Address
-
12515 E 55th St Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-091-2013
- Event ID
- 62924
- Recall initiation date
- April 8, 2011
- Center classification date
- December 11, 2012
- Code info
- Lot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12
- More code info
- —