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
Reported: December 25, 2013 Initiated: December 6, 2013 #D-379-2014
Product Description
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
Reason for Recall
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 215,340 vials
- Distribution
- Nationwide, Puerto Rico, Canada, New Zealand
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 215,340 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2013. Severity: Low. Recall number: D-379-2014.
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