D-888-2013 Class III Terminated
FDA drug recall D-888-2013 was initiated by Hi-Tech Pharmacal Co., Inc. on July 25, 2013 and is designated Class III. 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 U… The recall status is terminated (terminated May 16, 2016). Affected quantity: 58,812 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2013
- Initiation Date
- July 25, 2013
- Termination Date
- May 16, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58,812 tubes
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.
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
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Batch/Lot 619442, exp. 01/2015