Recalls / Class III

Class IIID-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.

Affected lot / code info

Batch/Lot 619442, exp. 01/2015

Why it was recalled

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

Recalling firm

Firm

Hi-Tech Pharmacal Co., Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

369 Bayview Ave, Amityville, New York 11701-2801

Distribution

Quantity

58,812 tubes

Distribution pattern

Nationwide and Puerto Rico

Timeline

Recall initiated

2013-07-25

FDA classified

2013-08-13

Posted by FDA

2013-08-21

Terminated

2016-05-16

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-888-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.