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Recall Observatory FDA recall evidence

Drug product

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL

D-1239-2015

June 29, 2015

Class III

Product summary

Firm
Qualitest Pharmaceuticals
Event
Event 71646
Status
Terminated
Classification
Class III
Quantity
47,376 bottles
Official record key
drug-enforcement:D-1239-2015

Official wording

Reason: Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Code information: 100 count (NDC 0603-3968-21); LOTS# T144F13A, T130G13B, T132G13A, exp date 6/15, T115D14A, exp date 3/16; 500 count (NDC 0603-3968-28), LOT# T144F13B exp date 6/15; and 1000 count (NDC 0603-3968-32); LOTS # T144F13C, T132G13B, exp date 6/15, T115D14B, exp date 3/16

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable