Hospira Recalls Magnesium Sulfate Injection Due to Particulate Matter
Hospira Inc. is recalling specific lots of Magnesium Sulfate Injection due to confirmed particulate matter. The recall covers 88,500 vials distributed in the US and several Middle Eastern countries.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Hospira Inc. is recalling 88,500 vials of Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (NDC 0409-2168-02) due to a confirmed customer complaint regarding the presence of particulate matter. The affected product is packaged in 25 vials per box and is available by prescription only.
The recall includes Lot # 50-343-DK* (where the lot number may be followed by numbers from 01 to 99) with an expiration date of 01FEB2017. These products were distributed nationwide in the United States, as well as in the United Arab Emirates, Kuwait, and Bahrain.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or a replacement. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 88,500
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 (3)
- Lot #: 50-343-DK*
- Exp 01FEB2017
- note that the lot number may be followed by numbers from 01 to 99.
Distribution
Distributed nationwide across the United States.
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