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Recall Observatory FDA recall evidence

Drug product

Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06

D-0490-2024

April 24, 2024

Class III

Product summary

Firm
Acella Pharmaceuticals, LLC
Event
Event 94485
Status
Terminated
Classification
Class III
Quantity
7104 Bottles
Official record key
drug-enforcement:D-0490-2024

Official wording

Reason: Subpotent drug

Code information: Lot # 22085 Exp. date 08/02/2024

Distribution pattern: Nationwide in the US and Puerto Rico.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent