Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90

Recall Number: D-0598-2018

Firm: Dr. Reddy's Laboratories, Inc.

Classification: Class III

Status: Terminated

Report Date: 20180321

Initiation Date: 20180308

Termination Date: 20190429

Reason for Recall

Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.

Product Description

Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90