Recalls / Class III
Class IIID-0892-2018
Product
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
- Affected lot / code info
- lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date.
Recalling firm
- Firm
- Qualgen, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 14844 Bristol Park Blvd, Edmond, Oklahoma 73013-1891
Distribution
- Quantity
- 2,940 pellets
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-06-08
- FDA classified
- 2018-06-29
- Posted by FDA
- 2018-07-11
- Terminated
- 2020-11-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0892-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.