Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coven
Summary
The FDA issued a Class II for Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Markete by Rhodes Pharmaceuticals, L.P.. Reason: Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle.
Details
Source
Drug Recall
External ID
D-0794-2021
Action Date
2021-09-22
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot # WP5K0Y, exp. date 02/28/2023
Quantity Affected: 55,344/100 count bottles
Reason for Recall
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Distribution
Product was distributed nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-19
Company
Coventry, RI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Rhodes Pharmaceuticals, L.P.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rhodes Pharmaceuticals, L.P. have FDA actions?
This is the only FDA action we have on record for Rhodes Pharmaceuticals, L.P. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0794-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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