Recalls / Class II
Class IID-0673-2018
Product
Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
- Affected lot / code info
- Lot#: 20171201@84, BUD: 05/30/2018; 20180125@31, BUD 07/24/2018; 20180209@106, BUD 08/08/2018; 20171011@69, BUD 04/09/2018; 20171019@10, BUD 04/17/2018; 20171106@103, BUD 05/05/2018.
Why it was recalled
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Recalling firm
- Firm
- Partell Specialty Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5835 S Eastern Ave Ste 101, Las Vegas, Nevada 89119-3031
Distribution
- Distribution pattern
- NV only
Timeline
- Recall initiated
- 2018-03-22
- FDA classified
- 2018-04-17
- Posted by FDA
- 2018-04-25
- Terminated
- 2019-01-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0673-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.