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.
Product description
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.
Lot numbers, UPCs & expiration codes
62QJ, Exp 12/11
Where it was sold
VA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-090-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 8, 2011
- FDA report date
- Dec 19, 2012
- Quantity
- 5 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Physicians Total Care, Inc.
Original FDA data
Every field from FDA enforcement report D-090-2013, exactly as published.
Show all FDA fields
- City
- Tulsa
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 62924
- Address
- 12515 E 55th St Ste 100
- Code information
- 62QJ, Exp 12/11
- Postal code
- 74146-6234
- Report date
- Dec 19, 2012
- Product type
- Drugs
- Recall number
- D-090-2013
- Classification
- Class III
- Recalling firm
- Physicians Total Care, Inc.
- Product quantity
- 5 bottles
- Termination date
- Feb 22, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- VA
- Recall initiation date
- Apr 8, 2011
- Initial firm notification
- FAX
- Center classification date
- Dec 11, 2012