Recalls / Class II
Class IID-0893-2017
Product
Estradiol 15 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: 69761-015-01
- Affected lot / code info
- Lot# C028; Exp. 02/28/18 Lot# C005; Exp. 07/11/17 Lot# B142; Exp. 11/21/17 Lot# B114; Exp. 10/10/17 Lot# B099; Exp. 09/16/17 Lot# B069; Exp. 07/12/17 Lot# B048; Exp. 06/6/17
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
- 6,227 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-0893-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.