Hospira Recalls Magnesium Sulfate Injection Due to High Potency
Hospira, Inc. is recalling 164,568 containers of Magnesium Sulfate in Water for Injection because the product contained higher levels of magnesium sulfate than specified.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Hospira, Inc. is recalling 164,568 containers of Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container. The product is identified by NDC 0409-6729-24 and Lot # 04510KL* (where the lot number may have 01 or 02 following it), with an expiration date of 01OCT2012. The recall was initiated because the product had above specification assay results for the percentage of magnesium sulfate.
The affected product was distributed nationwide. This is a prescription-only medication intended for intravenous use. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
- Brand
- MAGNESIUM SULFATE IN WATER
- Manufacturer
- Hospira, Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 164,568
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 #: 04510KL*
- Exp 01OCT2012
- *lot number may have 01 or 02 following it
Distribution
Distributed nationwide across the United States.
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