PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: March 21, 2018 Initiated: March 8, 2018 #D-0598-2018

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.

Details

Units Affected
4,152 tubes
Distribution
Product was distributed Nationwide in the USA.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 4,152 tubes.
Why was this product recalled?
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 21, 2018. Severity: Low. Recall number: D-0598-2018.