Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL a...

FDA Recall #D-0642-2018 — Class II — March 22, 2018

Recall #D-0642-2018 Date: March 22, 2018 Classification: Class II Status: Terminated

Product Description

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

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

Distribution

NV only

Code Information

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.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated