D-0599-2024 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2024
- Initiation Date
- June 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 868 tubes
Product Description
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Reason for Recall
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #, DI2303B, Exp 12/31/2024