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Recall Observatory FDA recall evidence

Drug product

Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05

D-0482-2026

March 18, 2026

Class III

Product summary

Firm
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Event
Event 98624
Status
Terminated
Classification
Class III
Quantity
299 bottles
Official record key
drug-enforcement:D-0482-2026

Official wording

Reason: Subpotent Drug

Code information: Lot 4212D4; Exp. 07/31/2026

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent