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Recall Observatory FDA recall evidence

Drug product

CVS Health Natural Sleep Aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895

D-0505-2022

January 24, 2022

Class II

Product summary

Firm
Ultra Seal Corporation
Event
Event 89464
Status
Terminated
Classification
Class II
Quantity
241,560 bottles
Official record key
drug-enforcement:D-0505-2022

Official wording

Reason: cGMP deviations

Code information: Lot #: 18L124, Exp. Date 02/2022; 19D029, Exp. Date 04/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations