Methylcobalamin 5000 mcg/mL Injection recalled over sterility concerns

Recall date

September 12, 2016

Source

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

Official notice title

The Apothecary Shoppe LLC recalls Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compoundin…

Recall number

D-0002-2017

FDA classification

Class II

Brand / firm

The Apothecary Shoppe LLC

Sold / distributed

Oklahoma

Why it was recalled

Lack of Assurance of Sterility; medication was sterilized with a recalled filter

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

What was recalled

Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK