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
Product summary
- 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
out-of-specification