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
Reported: July 17, 2024 Initiated: June 24, 2024 #D-0599-2024
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
Reason for Recall
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Details
- Recalling Firm
- Rising Pharma Holding, Inc.
- Units Affected
- 868 tubes
- Distribution
- Nationwide in the USA
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Rising Pharma Holding, Inc.. Units affected: 868 tubes.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2024. Severity: Low. Recall number: D-0599-2024.
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