Recalls / Class II
Class IID-0642-2018
Product
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
- Affected lot / code info
- a) Lot #: 20180123@9, 20171222@11, BUD 4/14/2018, 20180214@7, BUD 08/14/2018. b) Lot #: 20180221@3,BUD 08/21/2018, 20180214@6; BUD 08/14/2018.
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-0642-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.