Hospira Recalls Magnesium Sulfate Bags Due to Incorrect Barcodes
Hospira is recalling 181,704 bags of Magnesium Sulfate in Dextrose because some units may have incorrect barcodes that scan as heparin sodium.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 classified this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a minimum score of 4 (Severe) due to the reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Hospira, Inc. is recalling 181,704 bags of Magnesium Sulfate in 5% Dextrose Injection, USP, 10 mg/mL (100 mL bags). The recall is due to a labeling error where some units may be mislabeled with an incorrect barcode on the immediate container.
The incorrect barcode may scan as heparin sodium 2000 USP units/1000 mL in 0.9% sodium chloride injection. This mislabeling could lead to the administration of the wrong medication. The affected product is Lot 42-120-JT, with an expiration date of 01DEC2015.
The product was distributed nationwide. Healthcare providers and patients should check their inventory for this specific lot number and expiration date. If found, the product should not be used and should be returned to the supplier or the manufacturer.
The recalled product
- Product
- MAGNESIUM SULFATE IN DEXTROSE (MAGNESIUM SULFATE IN DEXTROSE)
- Brand
- MAGNESIUM SULFATE IN DEXTROSE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Affected units
- 181,704
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: 42-120-JT
- Exp 01DEC2015
UPCs (1)
- 003040967272
Distribution
Distributed nationwide across the United States.
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