FDA Drug Moderate Class II Terminated

Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Reported: November 25, 2015 Initiated: October 16, 2015 #D-0348-2016

Product Description

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm: Downing Labs, LLC
Units Affected: 363 vials
Distribution: Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Location: Dallas, TX

Frequently Asked Questions

What product was recalled? ▼

Methylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435. Recalled by Downing Labs, LLC. Units affected: 363 vials.

Why was this product recalled? ▼

Lack of Assurance of Sterility

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on November 25, 2015. Severity: Moderate. Recall number: D-0348-2016.