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: July 17, 2013 Initiated: May 21, 2013 #D-688-2013
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 Specification
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 80,480 vials
- Distribution
- Nationwide and Puerto Rico
- 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: 80,480 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specification
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2013. Severity: Low. Recall number: D-688-2013.
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