FDA recall D-888-2013

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.

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

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-07-25

Report date

2013-08-21

Termination date

2016-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Amityville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-888-2013