The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66295-001·Announced 2013-10-16

Hospira Recalls Bupivacaine Hydrochloride Vials Due to Sterility Concerns

Hospira is recalling 187,150 vials of Bupivacaine Hydrochloride with Epinephrine due to a lack of assurance of sterility and potential vial breakage.

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 and involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or adverse health consequences.

Plain-English summary

Hospira, Inc. is recalling 187,150 vials of 0.5% Bupivacaine Hydrochloride and Epinephrine 1:200,000 Injection, 10 mL, Single-Dose Vial (NDC 0409-9045-01). The recall is being conducted due to a lack of assurance of sterility and the potential for vial breakage.

The affected product is identified by Lot 17-400-EV* and 17-401-EV*, noting that the lot number may be followed by 01. The product was distributed nationwide, as well as to Guam and Abu Dhabi.

Healthcare providers and patients should stop using the affected vials and contact Hospira, Inc. for further instructions or a replacement. This recall is classified as FDA Class II.

The recalled product

Product
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
Brand
BUPIVACAINE HYDROCHLORIDE
Manufacturer
Hospira Inc.
Category
Drug — Injectable Anesthetic
Hazard
Affected units
187,150

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 (1)

  • Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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Same brand · BUPIVACAINE HYDROCHLORIDE

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