The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-616-2013·Announced 2013-07-03

Hospira Recalls 20% Dextrose Injection Due to Possible Leaking Bags

Hospira is voluntarily recalling 20% Dextrose Injection, USP, 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

Hospira, Inc. is voluntarily recalling 20% Dextrose Injection, USP, in 500 mL and 1000 mL containers. The recall is being conducted due to possible leaking bags, which raises a lack of assurance of sterility for the affected products.

The recall covers specific lots of the product, including NDC 0409-7935-19, NDC 0409-7953-30, and NDC 0409-7953-48. A total of 216,396 units were distributed nationwide, as well as to Puerto Rico, the U.S. Virgin Islands, Libya, and Saudi Arabia.

Healthcare providers and facilities should check their inventory for the affected lot numbers and expiration dates listed in the recall notice. Patients should consult their healthcare provider if they have received or used the recalled product.

The recalled product

Product
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Manufacturer
Hospira Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
216,396

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 (6)

  • Lot #: a) 09-183-JT
  • Exp 3/13
  • b) 01-081-JT
  • Exp 7/12
  • c) 07-078-JT
  • 91-083-JT

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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