Reported Jul 17, 2024 · Ongoing
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301;…
Rising Pharma Holding, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rising Pharma Holding, Inc. · 2 Tower Center Blvd Ste 1401 · East Brunswick, NJ · 08816-1149
Is this the product you have?
- Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd
- ByLyne Laboratories, Inc., Brockton, MA 02301; Mfd
- ForRising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
- Lot codes and dates
Lot #DI2303BExp 12/31/2024
- Amount recalled
- 868 tubes
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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