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Recall Observatory FDA recall evidence

Drug product

Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

D-0833-2018

May 04, 2018

Class III

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 80045
Status
Terminated
Classification
Class III
Quantity
1,348 bottles
Official record key
drug-enforcement:D-0833-2018

Official wording

Reason: Subpotent

Code information: Lot # HT659-6, expiration date 08/11/2019 LT168-7, expiration date 11/10/2019

Distribution pattern: Product was distributed to physicians and internet sales throughout the United States and Hong Kong, Panama, UK, China, Jordan, Qatar, Kuwait, and Central America.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent