D-0598-2018 Class III Terminated
FDA drug recall D-0598-2018 was initiated by Dr. Reddy's Laboratories, Inc. on Mar 8, 2018 and is designated Class III. Reason for recall: Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing. The recall status is terminated (terminated Apr 29, 2019). Affected quantity: 4,152 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 21, 2018
- Initiation Date
- Mar 8, 2018
- Termination Date
- Apr 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0598-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026