FDAClass IIApril 25, 2018

TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable recall: Sterility Concern

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

Why was TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 20180212@22, BUD 03/29/2018; 20180226@64, BUD 04/02/2018.

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
Recalling firm
Partell Specialty Pharmacy
Quantity
15 vials
Distribution
NV only
Recall date
April 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls