FDA Drug Recalls

Recalls / Class II

Class IID-0657-2018

Product

Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Affected lot / code info
Lot #: 20171228@15, BUD 03/28/2018

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-0657-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls