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Recall Observatory FDA recall evidence

Drug product

Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04

D-0481-2026

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
2895 bottles
Official record key
drug-enforcement:D-0481-2026

Official wording

Reason: Subpotent Drug

Code information: Lot 4212D2; Exp. 07/03/2026

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent