Why it was recalled
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
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
Lot numbers, UPCs & expiration codes
Lot # MGEC
Where it was sold
Product was distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0598-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 8, 2018
- FDA report date
- Mar 21, 2018
- Quantity
- 4,152 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0598-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 79472
- Address
- 107 College Rd E
- Code information
- Lot # MGEC
- Postal code
- 08540-6623
- Report date
- Mar 21, 2018
- Product type
- Drugs
- Recall number
- D-0598-2018
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 4,152 tubes
- Termination date
- Apr 29, 2019
- Reason for recall
- Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed Nationwide in the USA.
- Recall initiation date
- Mar 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2018