Drug Enforcement D-0599-2024

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

Status

Ongoing

Classification

Class III

Report Date

July 17, 2024

Termination Date

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Product Information

Product description
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
Product quantity
868 tubes
Reason for recall
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Rising Pharma Holding, Inc.
Address
2 Tower Center Blvd Ste 1401, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0599-2024
Event ID
94854
Recall initiation date
June 24, 2024
Center classification date
July 16, 2024
Code info
Lot #, DI2303B, Exp 12/31/2024
More code info
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