March 2021 FDA Recall Drug by X-gen Pharmaceuticals Inc.
D-0328-2021 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by X-gen Pharmaceuticals Inc. on March 19, 2021 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0328-2021
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
03-19-2021
04-14-2021
720 100-count (10x10 blister strips)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
X-Gen Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed Nationwide in the USA
12-07-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# CFMBX, EXP 9/2022
