Drug product
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00
D-0245-2019
Product summary
- Event
- Event 81554
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0245-2019
Official wording
Reason: Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Code information: Lot #: A0A0253, Exp. 02/2019; Lot #: B0369427-112717, Exp. 08/2019
Distribution pattern: 1 vial was distributed to a medical facility in Mayville, NY.
Derived failure modes
-
Potency or specification failure
Out-of-Specification