Why it was recalled
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Product description
Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
Lot numbers, UPCs & expiration codes
Lots: A002 Exp.: 10/23/2015; A003 Exp.: 10/25/2015; A009 Exp.: 11/01/2015; A011 Exp.: 11/2/2015; A014 Exp.: 11/8/2015; A016 Exp.: 11/10/2015; A027 Exp.: 11/20/2015; A028 Exp.: 11/21/2015; A030 Exp.: 11/22/2015; A032 Exp.: 11/23/2015; A037 Exp.: 11/24/2015; A039 Exp.: 11/27/2015; A042 Exp.: 11/28/2015; A044 Exp.: 11/29/2015; A050 Exp.: 12/06/2015; A051 Exp.: 12/10/2015; A053 Exp.: 12/12/2015; A062 Exp.: 12/20/2015; A065 Exp.: 12/28/2015
Where it was sold
Nationwide
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-0386-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2015
- FDA report date
- Dec 2, 2015
- Quantity
- 4,221 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualgen
Original FDA data
Every field from FDA enforcement report D-0386-2016, exactly as published.
Show all FDA fields
- City
- Edmond
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 72401
- Address
- 14844 Bristol Park Blvd
- Code information
- Lots: A002 Exp.: 10/23/2015; A003 Exp.: 10/25/2015; A009 Exp.: 11/01/2015; A011 Exp.: 11/2/2015; A014 Exp.: 11/8/2015; A016 Exp.: 11/10/2015; A027 Exp.: 11/20/2015; A028 Exp.: 11/21/2015; A030 Exp.: 11/22/2015; A032 Exp.: 11/23/2015; A037 Exp.: 11/24/2015; A039 Exp.: 11/27/2015; A042 Exp.: 11/28/2015; A044 Exp.: 11/29/2015; A050 Exp.: 12/06/2015; A051 Exp.: 12/10/2015; A053 Exp.: 12/12/2015; A062 Exp.: 12/20/2015; A065 Exp.: 12/28/2015
- Postal code
- 73013-1891
- Report date
- Dec 2, 2015
- Product type
- Drugs
- Recall number
- D-0386-2016
- Classification
- Class II
- Recalling firm
- Qualgen
- Product quantity
- 4,221 vials
- Termination date
- Mar 30, 2017
- Reason for recall
- Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 9, 2015
- Initial firm notification
- Center classification date
- Nov 24, 2015