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Recall Observatory FDA recall evidence

Drug product

Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01

D-0248-2018

January 22, 2018

Class III

Product summary

Firm
Ascent Pharmaceuticals, Inc.
Event
Event 78990
Status
Terminated
Classification
Class III
Quantity
45,875 bottles
Official record key
drug-enforcement:D-0248-2018

Official wording

Reason: Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

Code information: Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; Label Error