Hospira Recalls Marcaine Injection Due to Sterility and Potency Issues
Hospira is recalling 15 vials of Marcaine 0.25% injection because a glass defect allowed water to enter, compromising sterility and reducing drug potency.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a loss of sterility assurance and subpotent drug, which poses a significant risk of serious adverse health consequences.
Plain-English summary
Hospira Inc., A Pfizer Company, is recalling 15 vials of Marcaine (bupivacaine hydrochloride) 0.25% injection, USP. The affected product is the 50 mL Multiple-Dose Vial, NDC 0409-1587-50, with Lot # 60295DD and an expiration date of 1DEC2017. The recall covers distribution nationwide and in Puerto Rico.
The recall was initiated due to a defect in the glass vial that prevented the stopper from forming a proper seal. This defect allowed water to ingress into the vial, which diluted the product and caused it to be less than the labeled potency. Additionally, the breach in the seal compromised the assurance of sterility for the medication.
Healthcare providers and patients should stop using the affected vials immediately. The product is a prescription-only medication intended for perineural use. Users should contact their healthcare provider or the recalling firm for further instructions on how to handle or return the product.
The recalled product
- Product
- MARCAINE (BUPIVACAINE HYDROCHLORIDE)
- Brand
- MARCAINE
- Manufacturer
- Hospira Inc., A Pfizer Company
- Category
- Drug — Prescription Injection
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 60295DD
- Ep 1DEC2017
Distribution
Part of a larger recall action
This product is one of 2 recalled by Hospira Inc., A Pfizer Company under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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