Fresenius Kabi Recalls Magnesium Sulfate Injection Due to Glass Particulates
Fresenius Kabi is recalling 15,625 vials of Magnesium Sulfate Injection, USP, 50% due to the presence of glass particulate matter.
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.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 15,625 vials of Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial. The product is identified by NDC 63323-064-50, Lot # 6103882, with an expiration date of 10/14. The recall is classified as Class I by the FDA.
The recall was initiated because glass particulate matter was observed in a retention sample during an annual review. The affected product was distributed nationwide.
Healthcare providers and patients should discontinue use of the affected vials and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 15,625
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 #: 6103882
- Exp 10/14
Distribution
Distributed nationwide across the United States.
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