FDA Drug recall D-0328-2021
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc by X Gen Pharmaceuticals, citing failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0328-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-19 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | X Gen Pharmaceuticals |
| Distribution | US |
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
Reason
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Identifiers
| code_info | Lot # CFMBX, EXP 9/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0328-2021%22
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