October 2023 FDA Recall Oxaydo by Zyla Life Sciences Us Inc.
D-0094-2024 - Sub-potent Drug
This Class III drug recall was voluntarily initiated by Zyla Life Sciences Us Inc. on October 20, 2023 for the product Oxaydo. The FDA reported the reason for recall as sub-potent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0094-2024
Sub-potent Drug: Lower potency than labeled.
10-20-2023
11-15-2023
3,792 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zyla Life Sciences US 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.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
Batch or Lot Expiration Information
Lot# Lot 22W02, Exp 01/31/2025
