Skip to content
Recall Observatory FDA recall evidence

Drug product

Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15

D-0026-2015

October 02, 2014

Class III

Product summary

Firm
Valeant Pharmaceuticals International
Event
Event 69359
Status
Terminated
Classification
Class III
Quantity
1663 tubes
Official record key
drug-enforcement:D-0026-2015

Official wording

Reason: Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point

Code information: Lot number 13052B, Exp. 03/2015, NDC16781-382-15

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent