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Recall Observatory FDA recall evidence

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

August 19, 2021

Class II

Product summary

Firm
Rhodes Pharmaceuticals, L.P.
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

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets