Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-379-2014

December 06, 2013

Class III

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 67054
Status
Terminated
Classification
Class III
Quantity
215,340 vials
Official record key
drug-enforcement:D-379-2014

Official wording

Reason: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

Code information: Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14

Distribution pattern: Nationwide, Puerto Rico, Canada, New Zealand

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification