Class III · Low risk Ongoing
Diflorasone Diacetate Ointment
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Diflorasone Diacetate Ointment USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
What was recalled
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.
- Recalling firm
- Teligent Pharma, Inc.
- NDC code
- 52565-063-60
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0701-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Diflorasone recalls
See all
Class II · Moderate risk Terminated
Diflorasone Diacetate Ointment USP
Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II · Moderate risk Terminated
Diflorasone Diacetate Ointment USP
Reason Presence of Foreign Substance: Foreign particles observed during routine stability testing.
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