Drug product
Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
D-888-2013
Product summary
- Event
- Event 65803
- Status
- Terminated
- Classification
- Class III
- Quantity
- 58,812 tubes
- Official record key
drug-enforcement:D-888-2013
Official wording
Reason: Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Code information: Batch/Lot 619442, exp. 01/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up