Hospira Inc., A Pfizer Company recalls Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira,
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.
Recall notice
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.
Contact the company & request your remedy
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Source Page by GovInfoNow · govinfonow.com/recall/42437-hospira-inc-a-pfizer-company-recalls-marcaine-0-25-bupivacaine · Recall date September 16, 2016 · FDA enforcement record: FDA #D-0096-2017
Cite this page
“Hospira Inc., A Pfizer Company recalls Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira,.” GovInfoNow, recall dated September 16, 2016. https://govinfonow.com/recall/42437-hospira-inc-a-pfizer-company-recalls-marcaine-0-25-bupivacaine. Based on FDA recall #D-0096-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2017%22&limit=1).
How to tell if you have this one
- Brand
Hospira Inc. A Pfizer Company- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico- NDC
0409-1559-18, 0409-1559-10, 0409-1559-19, 0409-1559-30, 0409-1560-18, 0409-1560-10, 0409-1560-19, 0409-1560-29, 0409-1582-18, 0409-1582-10, 0409-1582-19, 0409-1582-29, 0409-1587-50, 0409-1610-50, 0409-1746-70, 0409-1746-10, 0409-1746-71, 0409-1746-30, 0409-1749-70, 0409-1749-10, 0409-1749-71, 0409-1749-29, 0409-1752-50, 0409-1755-50, 0409-2510-01, 0409-2510-25, 0409-7535-01, 0409-7535-25, 0409-1250-01, 0409-1250-25, 0409-5010-01, 0409-5010-25, 0409-1530-01, 0409-1530-25, 0409-0525-01, 0409-0525-25, 0409-7510-01, 0409-7510-25, 0409-2253-01, 0409-2253-25
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| 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.; Lot #: 60295DD, Ep 1DEC2017 | 15 vials |
| D-0097-2017 | 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 #: 59310DD, Exp 1NOV2017 | 4768 vials |
Contact Hospira Inc. A Pfizer Company
We’ve drafted a message you can send Hospira Inc. A Pfizer Company to request your refund or repair — edit it as you like.
Subject: Recall D-0096-2017 — Hospira Inc. A Pfizer Company Hospira Inc., A Pfizer Company recalls Marcaine 0.25% (bupivacaine HC Hello, I own a Hospira Inc., A Pfizer Company recalls Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, that is covered by recall D-0096-2017 from Hospira Inc. A Pfizer Company. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0096-2017 (September 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0096-2017 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.