Recalls / Class II
Class IID-0896-2017
Product
Estradiol 6 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: 69761-006-01.
- Affected lot / code info
- Lot# C046; Exp. 03/15/18 Lot# C025; Exp. 08/23/17 Lot# B159; Exp. 12/28/17 Lot# B121; Exp. 10/10/17 Lot# B118; Exp. 10/17/17 Lot# B086; Exp. 08/29/17 Lot# B068; Exp. 07/11/17 Lot# B053; Exp. 06/14/17 Lot# B034; Exp. 04/26/17
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
- 4,815 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-0896-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.