Reported Dec 25, 2013 · Terminated
FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals,…
Fresenius Kabi USA, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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
- Lot codes and dates
Lot 6104649Exp. 02/146104789Exp. 03/146105069Exp. 04/14
- Amount recalled
- 215,340 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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