Drug product
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-001-24
D-0616-2017
Product summary
- Event
- Event 76733
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72072 units
- Official record key
drug-enforcement:D-0616-2017
Official wording
Reason: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Code information: Lot #: A060205; A060209, Exp.Jan 2018
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility