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Recall Observatory FDA recall evidence

Drug product

T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT

D-0832-2018

May 04, 2018

Class III

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 80045
Status
Terminated
Classification
Class III
Quantity
952 bottles
Official record key
drug-enforcement:D-0832-2018

Official wording

Reason: Subpotent

Code information: Lot # MT390-8, expiration date 12/01/2020 GU925-4, expiration date 07/05/2020

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