FDASeptember 16, 2016drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

hospira inc a pfizerhospirahospira inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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