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
Reported: April 14, 2021 Initiated: March 19, 2021 #D-0328-2021
Product Description
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 for Recall
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Details
- Recalling Firm
- X-Gen Pharmaceuticals Inc.
- Units Affected
- 720 100-count (10x10 blister strips)
- Distribution
- Distributed Nationwide in the USA
- Location
- Horseheads, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by X-Gen Pharmaceuticals Inc.. Units affected: 720 100-count (10x10 blister strips).
Why was this product recalled? ▼
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 14, 2021. Severity: Moderate. Recall number: D-0328-2021.
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