Fresenius Kabi Recalls Folic Acid Injection Vials for Impurity Failures
Fresenius Kabi USA is recalling folic acid injection vials due to failed impurity and degradation specifications at 14 and 15 months.
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
Fresenius Kabi USA, LLC is recalling Folic Acid Injection, USP, 5 mg/mL, 10 mL multiple-dose vials. The recall involves 215,340 vials distributed nationwide, in Puerto Rico, Canada, and New Zealand. The affected lots are 6104649 (Exp. 02/14), 6104789 (Exp. 03/14), and 6105069 (Exp. 04/14).
The recall was initiated because the product failed impurities and degradation specifications, specifically showing out-of-specification results at the 14 and 15-month time points. The FDA has classified this recall as Class III, 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 vials and contact their pharmacist or the recalling firm for further instructions. Consumers should not use the product if they have received it from a healthcare provider.
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
- 215,340
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 (6)
- Lot 6104649
- Exp. 02/14
- 6104789
- Exp. 03/14
- 6105069
- Exp. 04/14
Distribution
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