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Recall Observatory FDA recall evidence

Drug product

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21

D-1572-2014

August 27, 2014

Class II

Product summary

Firm
Qualitest Pharmaceuticals
Event
Event 69157
Status
Terminated
Classification
Class II
Quantity
23,544 bottles
Official record key
drug-enforcement:D-1572-2014

Official wording

Reason: Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

Code information: T062A14A, Exp 12/15

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.