D-0794-2021 Class II Terminated
FDA drug recall D-0794-2021 was initiated by Rhodes Pharmaceuticals, L.P. on August 19, 2021 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle The recall status is terminated (terminated March 7, 2023). Affected quantity: 55,344/100 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 22, 2021
- Initiation Date
- August 19, 2021
- Termination Date
- March 7, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55,344/100 count bottles
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
Reason for Recall
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Distribution Pattern
Product was distributed nationwide.
Code Information
Lot # WP5K0Y, exp. date 02/28/2023