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Recall Observatory FDA recall evidence

Drug 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

D-0599-2024

June 24, 2024

Class III

Product summary

Firm
Rising Pharma Holding, Inc.
Event
Event 94854
Status
Ongoing
Classification
Class III
Quantity
868 tubes
Official record key
drug-enforcement:D-0599-2024

Official wording

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

Code information: Lot #, DI2303B, Exp 12/31/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications