D-0598-2018 Class III Terminated

Recalled by Dr. Reddy's Laboratories, Inc. — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
March 21, 2018
Initiation Date
March 8, 2018
Termination Date
April 29, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,152 tubes

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

Reason for Recall

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

Distribution Pattern

Product was distributed Nationwide in the USA.

Code Information

Lot # MGEC