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Recall Observatory FDA recall evidence

Drug product

Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 67877-0573-05

D-1124-2022

January 15, 2021

Class I

Product summary

Firm
Calvin Scott & Company, Inc.
Event
Event 90183
Status
Terminated
Classification
Class I
Quantity
10 bottles
Official record key
drug-enforcement:D-1124-2022

Official wording

Reason: Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 mg tablets and a bottle labeled as Benzphetamine 50 mg tablets contained Benzonatate 100 mg capsules.

Code information: CSI Lot: CS-20180W-004, Exp 3/22

Distribution pattern: 1 physician in Alpharetta, GA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-up