Drug product
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
D-0974-2016
Product summary
- Event
- Event 74316
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10
- Official record key
drug-enforcement:D-0974-2016
Official wording
Reason: CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Code information: Lot#: 47312-1, Exp 01/2018
Distribution pattern: IN, GA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Out of specification