TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, ...
FDA Recall #D-0645-2018 — Class II — March 22, 2018
Product Description
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.
Recalling Firm
Partell Specialty Pharmacy — Las Vegas, NV
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
15 vials
Distribution
NV only
Code Information
Lot#: 20180212@22, BUD 03/29/2018; 20180226@64, BUD 04/02/2018.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated