Recalls / Class II
Class IID-0386-2016
Product
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
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- Qualgen
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 14844 Bristol Park Blvd, N/A, Edmond, Oklahoma 73013-1891
Distribution
- Quantity
- 4,221 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-10-09
- FDA classified
- 2015-11-24
- Posted by FDA
- 2015-12-02
- Terminated
- 2017-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0386-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.