Reported Oct 19, 2016 · Terminated
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira,…
Hospira Inc., A Pfizer Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc., A Pfizer Company · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 59310DDExp 1NOV2017
- Amount recalled
- 4768 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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