Class III

Drug Recall: 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

Rising Pharma Holding, Inc. · June 24, 2024

Reason for Recall

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

868 tubes

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0599-2024

Status: ongoing

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