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Rising Pharma Holding, Inc. recalls Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd

Recalled July 17, 2024 · FDA recall D-0599-2024 · Rising Pharma Holding

Hazard
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit. · FDA Class III
Units
868 tubes
Sold at
Nationwide in the USA

Description

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

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
Manufacturer(s)
Rising Pharma Holding, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Rising Pharma Holding, Inc. recalls Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd | RecallWatchUSA