FDAFDA · Food and drugs·Recall number D-0096-2017
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
Published October 19, 2016 · Recall initiated: September 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MARCAINE
- Manufacturer
- Hospira Inc., A Pfizer Company
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot #: 60295DD, Ep 1DEC2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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