Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0390-2015·Announced 2015-02-25

Hospira Recalls Vancomycin Hydrochloride Injection Due to Temperature Excursions

Hospira Inc. is recalling 90,600 vials of Vancomycin Hydrochloride for Injection because the products experienced uncontrolled temperature excursions during transit.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves temperature excursions which may affect drug stability, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Hospira Inc. is recalling 90,600 vials of Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial. The recall is due to uncontrolled temperature excursions that occurred during transit. The affected product is identified by Lot # 35-315-DD and has an expiration date of 1NOV2015.

The distribution of the affected Vancomycin 1 g product was nationwide. Other lots of Vancomycin 500 mg, Ketorolac tromethamine, and Propofol were limited to a single shipment to The Harvard Drug Group in Livonia, MI, and remained within the distributor's control without further distribution.

Healthcare providers and patients should stop using the affected product and contact Hospira Inc. for further instructions. Consumers should not use the recalled medication and should return it to their pharmacy or healthcare provider.

The recalled product

Product: VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
Brand: VANCOMYCIN HYDROCHLORIDE
Manufacturer: Hospira Inc.
Category: Drug — Antibiotic Injection
Hazard: temperature-abuse
drug-stability
Affected units: 90,600

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 #: 35-315-DD
Exp 1NOV2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Hospira Inc. 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 4 products in this recall →

Same brand · VANCOMYCIN HYDROCHLORIDE

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Critical
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Same manufacturer · Hospira Inc.

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Low
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Same hazard · temperature abuse