The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-618-2013·Announced 2013-07-03

Hospira Recalls 1.5% Glycine Irrigation Due to Sterility Concerns

Hospira is voluntarily recalling 1.5% Glycine Irrigation, USP, 3000 mL, due to possible leaking bags that may compromise sterility.

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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in a medical irrigation product, which poses a significant risk of infection or serious injury if administered to patients, fitting the criteria for a Severe rating.

Plain-English summary

Hospira, Inc. is voluntarily recalling 1.5% Glycine Irrigation, USP, 3000 mL, Rx Only (NDC 0409-7974-08). The recall affects Lot # 95-057-JT with an expiration date of 11/12. A total of 40,988 units were distributed nationwide, as well as to Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that the product is being recalled because of possible leaking bags, which could potentially compromise the sterile nature of the irrigation solution.

Healthcare providers and facilities that have received this product should stop using it and contact Hospira, Inc. for further instructions. Consumers should not use this prescription-only product if they have it in their possession.

The recalled product

Product
1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
Manufacturer
Hospira Inc.
Category
Drug — Irrigation Solution
Hazard
Affected units
40,988

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 #: 95-057-JT
  • Exp 11/12

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 9 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 9 products in this recall →

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