FDA Recall D-0599-2024

Rising Pharma Holding, Inc. · East Brunswick, NJ

Class III Ongoing 689 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot #, DI2303B, Exp 12/31/2024

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 record

Recall number: D-0599-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-06-24
Classified by FDA Center: 2024-07-16
FDA published: 2024-07-17
Recalling firm: Rising Pharma Holding, Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): DIFLORASONE DIACETATE
Generic name(s): DIFLORASONE DIACETATE
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 64980-124
Route(s): TOPICAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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