Drug product
METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 25MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
D-0222-2023
Product summary
- Event
- Event 91332
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0222-2023
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Code information: t20221011@25 t20221011@37 t20221018@35 t20221121@29 t20221116@36 t20221116@36 t20221116@36 t20221116@36
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility