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Recall Observatory FDA recall evidence

Drug product

ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28

D-1405-2015

July 20, 2015

Class III

Product summary

Firm
Qualitest Pharmaceuticals
Event
Event 71776
Status
Terminated
Classification
Class III
Quantity
21552 units
Official record key
drug-enforcement:D-1405-2015

Official wording

Reason: Failed Tablet/Capsule Specifications; report of oversized and discolored tablets

Code information: CP0761501, Exp. 12/16

Distribution pattern: Nationwide and PR

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications; report of oversized and discolored tablets