Marcaine 0 recalled over sterility concerns

Recall date

September 16, 2016

Source

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

Official notice title

Hospira Inc., A Pfizer Company recalls Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc…

Recall number

D-0097-2017

FDA classification

Class II

Brand / firm

Hospira Inc., A Pfizer Company

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

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

What was recalled

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.