Fresenius Kabi Recalls Calcium Glucosate Injection Due to Missing Label
Fresenius Kabi USA LLC is recalling 155,900 vials of Calcium Glucosate Injection, USP, 10% due to missing labels. The recall is nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a documentation/packaging issue (missing label) rather than a direct safety defect.
Plain-English summary
Fresenius Kabi USA LLC (FK USA) is recalling 155,900 vials of Calcium Glucosate Injection, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial. The product is identified by Product Code 31110 and NDC 63323-311-10. The specific lot affected is 6004889, with an expiration date of 10/2014.
The recall was initiated because the vials are missing labels. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Healthcare providers and patients should stop using the affected vials and contact their supplier or the recalling firm for further instructions.
The recalled product
- Product
- CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
- Manufacturer
- Fresenius Kabi USA LLC (FK USA)
- Category
- Drug — Injection
- Hazard
- Affected units
- 155,900
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 6004889
- Expiration Date 10/2014
Distribution
Distributed nationwide across the United States.
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