Drug 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.
D-0636-2021
Product summary
- Event
- Event 87950
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,240 tubes
- Official record key
drug-enforcement:D-0636-2021
Official wording
Reason: Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Code information: Lot #: 16264, Exp Date Nov 2022
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance