Class III
Ongoing
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
This recall is currently active, issued July 17, 2024. It was issued by Rising Pharma Holding, Inc..
- Company
- Rising Pharma Holding, Inc.
- Recall Initiated
- June 24, 2024
- Posted
- July 17, 2024
- Recall Number
- D-0599-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 868 tubes
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #, DI2303B, Exp 12/31/2024
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