Fresenius Kabi Recalls Folic Acid Injection Due to Impurities
Fresenius Kabi USA is recalling 80,480 vials of Folic Acid Injection due to failed impurities and degradation specifications.
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 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
Fresenius Kabi USA, LLC is recalling 80,480 vials of Folic Acid Injection, USP, 5 mg/mL. The product is a 10 mL multiple-dose vial intended for intramuscular, intravenous, or subcutaneous use. The recall is being conducted because the product failed impurities and degradation specifications.
The affected product is identified by Lot # 6103883 with an expiration date of 10/2013. The NDC number is 63323-184-11. The product was distributed nationwide and in Puerto Rico.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Healthcare providers and patients should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 80,480
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 #: 6103883
- Exp 10/2013
Distribution
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