Recalls / Class II
Class IID-0636-2021
Product
Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
- Affected lot / code info
- Lot #: 16264, Exp Date Nov 2022
Why it was recalled
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 6,240 tubes
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2021-05-14
- FDA classified
- 2021-06-23
- Posted by FDA
- 2021-06-30
- Terminated
- 2022-08-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0636-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.