February 2022 FDA Recall Oxycodone Hydrochloride by American Health Packaging
D-0652-2022 - Impurity failure at 0-time of the repackaged lot.
This Class II drug recall was voluntarily initiated by American Health Packaging on February 22, 2022 for the product Oxycodone Hydrochloride. The FDA reported the reason for recall as impurity failure at 0-time of the repackaged lot.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0652-2022
Impurity failure at 0-time of the repackaged lot.
02-22-2022
03-16-2022
89,880 unit-dose cups
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.
American Health Packaging
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 in the USA
07-16-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
Batch or Lot Expiration Information
Lot# 1004276, Exp 11/30/2022
