Status
Terminated
Drug Enforcement D-888-2013
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
Classification
Class III
Report Date
August 21, 2013
Termination Date
May 16, 2016
Product Information
- Product description
- 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.
- Product quantity
- 58,812 tubes
- Reason for recall
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Hi-Tech Pharmacal Co., Inc.
- Address
-
369 Bayview Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-888-2013
- Event ID
- 65803
- Recall initiation date
- July 25, 2013
- Center classification date
- August 13, 2013
- Code info
- Batch/Lot 619442, exp. 01/2015
- More code info
- —