The Recall Desk
CriticalFDA (Drugs)·D-0668-2016·Announced 2016-02-24

Hospira Recalls Magnesium Sulfate Injection Bags Due to Incorrect Barcode Labeling

Hospira is recalling 213,600 bags of Magnesium Sulfate in Water for Injection because the primary bag labeling may be mislabeled with a barcode that scans as heparin sodium.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score of 5.

Plain-English summary

Hospira, Inc. is recalling 213,600 bags of Magnesium Sulfate in Water for Injection, 2 g Total, 50 mL Single-Dose Container. The product is identified by NDC 0409-6729-24, Lot 53-113-JT, and an expiration date of 1NOV2016. The recall is due to a labeling error where the primary bag labeling may be mislabeled with the wrong barcode, which scans in as heparin sodium.

The affected product was distributed nationwide. This recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death. The hazard involves the potential for medication administration errors due to the incorrect barcode scanning as a different drug.

Healthcare providers and facilities should stop using the affected product and contact Hospira for further instructions. Consumers should not use the product if they have it in their possession and should contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
Brand
MAGNESIUM SULFATE IN WATER
Manufacturer
Hospira Inc.
Affected units
213,600

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: 53-113-JT
  • Exp 1NOV2016

Distribution

Distributed nationwide across the United States.

Same brand · MAGNESIUM SULFATE IN WATER