Drug product
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
D-0328-2021
Product summary
- Event
- Event 87500
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720 100-count (10x10 blister strips)
- Official record key
drug-enforcement:D-0328-2021
Official wording
Reason: Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Code information: Lot # CFMBX, EXP 9/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification