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.
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 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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