Drug & medication recalls

Dr. Reddy's Laboratories, Inc. recalls Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ…

Recall date
March 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0598-2018
FDA classification
Class III
Brand / firm
Dr. Reddy's Laboratories, Inc.
Sold / distributed
Product was distributed Nationwide in the USA.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What 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

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