D-0598-2018 Class III Terminated
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