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-688-2013
Product summary
- Event
- Event 65213
- Status
- Terminated
- Classification
- Class III
- Quantity
- 80,480 vials
- Official record key
drug-enforcement:D-688-2013
Official wording
Reason: Failed Impurities/Degradation Specification
Code information: Lot #: 6103883, Exp 10/2013
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specification