FDA recall D-0645-2018

Product

TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Reason for recall

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

Distribution

NV only

Key facts

Status

Terminated

Initiation date

2018-03-22

Report date

2018-04-25

Termination date

2019-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0645-2018