Drug recall D-0599-2024

Class III Ongoing reported Jul 17, 2024

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

Reason for recall

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

Lots and codes

Lot #, DI2303B, Exp 12/31/2024

Recall details

Recalling firm
Rising Pharma Holding, Inc., East Brunswick, NJ
Quantity
868 tubes
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
June 24, 2024

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