Recalls / Class III
Class IIID-0598-2018
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
- Affected lot / code info
- Lot # MGEC
Why it was recalled
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 4,152 tubes
- Distribution pattern
- Product was distributed Nationwide in the USA.
Timeline
- Recall initiated
- 2018-03-08
- FDA classified
- 2018-03-14
- Posted by FDA
- 2018-03-21
- Terminated
- 2019-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0598-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.