The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0097-2017·Announced 2016-10-19

Hospira Recalls Marcaine Injection Vials Due to Sterility and Potency Defects

Hospira is recalling 4,768 vials of Marcaine 0.5% injection because a glass defect allowed water ingress, compromising sterility and reducing drug potency.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe rating under the rubric. The defect involves a loss of sterility assurance and subpotent drug, which are significant safety hazards for a perineural injection.

Plain-English summary

Hospira Inc., a Pfizer company, is recalling 4,768 vials of Marcaine (bupivacaine hydrochloride) 0.5% injection, USP. The affected product is the 250 mg/50 mL (5 mg/mL) multiple-dose vial, NDC 0409-1610-50, with lot number 59310DD and an expiration date of November 1, 2017. 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 enter the vial, which diluted the product and resulted in a potency lower than labeled. Additionally, the breach in the seal compromised the assurance of sterility for the medication.

Healthcare providers and facilities that have received this specific lot of Marcaine should stop using the product and contact Hospira for instructions on return or disposal. Patients who have received this medication should consult their healthcare provider if they have concerns about their treatment.

The recalled product

Product
MARCAINE (BUPIVACAINE HYDROCHLORIDE)
Brand
MARCAINE
Manufacturer
Hospira Inc., A Pfizer Company
Category
Drug — Injection
Hazard
Affected units
4,768

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 #: 59310DD
  • Exp 1NOV2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

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