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
D-0598-2018
Product summary
- Event
- Event 79472
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,152 tubes
- Official record key
drug-enforcement:D-0598-2018
Official wording
Reason: Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Code information: Lot # MGEC
Distribution pattern: Product was distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Out-of-specification