August 2021 FDA Recall Oxycodone Hydrochloride by Rhodes Pharmaceuticals, L.p.
D-0794-2021 - Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle

This Class II drug recall was voluntarily initiated by Rhodes Pharmaceuticals, L.p. on August 19, 2021 for the product Oxycodone Hydrochloride. The FDA reported the reason for recall as presence of foreign tablets/capsules; a single foreign tablet hydrochlorothiazide/lisinopril 25/20 was found in one bottle. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0794-2021

Reason for Recall
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Initiated
08-19-2021
Reported
09-22-2021
Quantity
55,344/100 count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88506
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Rhodes Pharmaceuticals, L.P.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-07-2023
Product Description About Product Description
Full technical description of the product.
Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01

Batch or Lot Expiration Information

Lot# WP5K0Y, exp. date 02/28/2023

Affected Packages Involved in this Recall

42858-001-01 Oxycodone Hydrochloride
42858-001-10 Oxycodone Hydrochloride
42858-002-01 Oxycodone Hydrochloride
42858-002-10 Oxycodone Hydrochloride
42858-003-01 Oxycodone Hydrochloride
42858-004-01 Oxycodone Hydrochloride
42858-005-01 Oxycodone Hydrochloride