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.
Reported: June 30, 2021 Initiated: May 14, 2021 #D-0636-2021
Product Description
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 for Recall
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Details
- Recalling Firm
- Teligent Pharma, Inc.
- Units Affected
- 6,240 tubes
- Distribution
- Nationwide in the United States
- Location
- Buena, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teligent Pharma, Inc.. Units affected: 6,240 tubes.
Why was this product recalled? ▼
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 30, 2021. Severity: Moderate. Recall number: D-0636-2021.
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