Drug & medication recalls Moderate risk

Methylcobalamin 5 recalled over sterility concerns

Recall date
June 10, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Vital Care Compounder recalls Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
Recall number
D-1054-2016
FDA classification
Class II
Brand / firm
Vital Care Compounder
Sold / distributed
MS

Why it was recalled

Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.

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 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS

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