Drug 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
D-0794-2021
Product summary
- Event
- Event 88506
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55,344/100 count bottles
- Official record key
drug-enforcement:D-0794-2021
Official wording
Reason: Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Code information: Lot # WP5K0Y, exp. date 02/28/2023
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets