FDA recall D-0794-2021

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

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.

Key facts

Status

Terminated

Initiation date

2021-08-19

Report date

2021-09-22

Termination date

2023-03-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Coventry, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0794-2021