FDA recall D-0598-2018

Dr. Reddy's Laboratories, Inc. · Class III · drug

Product

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

Product was distributed Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2018-03-08
Report date: 2018-03-21
Termination date: 2019-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0598-2018