Drug product
Gentamycin 80mg/1000cc 0.9% NS
D-1115-2014
Product summary
- Event
- Event 66856
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1115-2014
Official wording
Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Code information: All lot numbers within expiry.
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of Sterility