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FDAJune 24, 2024drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

rising pharma holdingrisingrising pharma

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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