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Recall Observatory FDA recall evidence

Drug product

DCL T Shampoo for Hair and Body ( Solution Coal Tar U.S.P. 3% and 0.6% Coal Tar), 300 ml/ 10.1 fl.oz. Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA, UPC 3574865069947

D-0087-2021

October 09, 2020

Class II

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 86579
Status
Terminated
Classification
Class II
Quantity
1,225 bottles
Official record key
drug-enforcement:D-0087-2021

Official wording

Reason: GMP Deviations

Code information: Lot #: DW913-9, Exp. Date Apr-22

Distribution pattern: Product was distributed throughout the United States, including Puerto Rico and internationally.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations