FDAHealthJune 24, 2024
Rising Pharma Holding, Inc. — Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswic
⚠️ Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 24, 2024
Nationwide in the USA
What's affected?
- Product
- 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
- Lot code
- #
Additional details
Lot #, DI2303B, Exp 12/31/2024
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 868 tubes.
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