Hospira Recalls Magnesium Sulfate Injection Due to pH Specification Failure
Hospira Inc. is recalling 106,900 vials of Magnesium Sulfate Injection, USP, 50% because 12-month stability testing failed pH specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences, aligning with the Moderate severity criteria for minor specification failures.
Plain-English summary
Hospira Inc. is recalling 106,900 vials of Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial. The product is intended for intravenous (IV) or intramuscular (IM) use and is prescription-only. The recall is limited to Lot # 39-569-DK, which has an expiration date of 3/1/2016.
The recall was initiated because 12-month stability testing failed to meet pH specifications. The affected product was distributed nationwide in the United States, as well as in Kuwait, Bahrain, and Israel.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 106,900
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 #: 39-569-DK
- Exp 3/1/2016
Distribution
Distributed nationwide across the United States.
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