Recalls / Class II
Class IID-0328-2021
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
- Affected lot / code info
- Lot # CFMBX, EXP 9/2022
Why it was recalled
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Recalling firm
- Firm
- X-Gen Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Daniel Zenker Dr, N/A, Horseheads, New York 14845-1014
Distribution
- Quantity
- 720 100-count (10x10 blister strips)
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-03-19
- FDA classified
- 2021-04-08
- Posted by FDA
- 2021-04-14
- Terminated
- 2022-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0328-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.