Drug product
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
D-0025-2015
Product summary
- Event
- Event 69359
- Status
- Terminated
- Classification
- Class III
- Quantity
- 34,218 tubes
- Official record key
drug-enforcement:D-0025-2015
Official wording
Reason: Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Code information: Lot numbers 13052C, exp 03/2015 and 13156A, exp 08/2015, NDC 43478-270-15
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent