Recalls / Class II
Class IID-0890-2017
Product
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
- Affected lot / code info
- Lot # B128; Exp. 11/1/17 Lot # B075; Exp. 08/3/17
Why it was recalled
CGMP deviations- Lack of Quality Assurance
Recalling firm
- Firm
- Qualgen
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 14844 Bristol Park Blvd, N/A, Edmond, Oklahoma 73013-1891
Distribution
- Quantity
- 1,666 pellets.
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2017-04-19
- FDA classified
- 2017-06-07
- Posted by FDA
- 2017-06-14
- Terminated
- 2021-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0890-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.