Pyridoxine Injection recalled over sterility concerns

Recall date

October 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Downing Labs, LLC recalls Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-…

Recall number

D-0373-2016

FDA classification

Class II

Brand / firm

Downing Labs, LLC

Sold / distributed

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

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435