FDA Drug recall D-0636-2021
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, Manufacture…
- FDA Drug
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of 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, Manufacture… by Teligent Pharma, citing presence of Foreign Substance: Foreign particles observed during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0636-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-14 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teligent Pharma |
| Distribution | US |
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.
Reason
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Identifiers
| code_info | Lot #: 16264, Exp Date Nov 2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0636-2021%22
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