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
Product summary
- 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
Subpotent