Diflorasone Diacetate Ointment recall: Impurity Out of Spec
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals…
Why was Diflorasone Diacetate Ointment recalled?
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #, DI2303B, Exp 12/31/2024
- Product
- Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals…
- Recalling firm
- Rising Pharma Holding, Inc.
- Quantity
- 868 tubes
- Distribution
- Nationwide in the USA
- Recall date
- July 17, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)