FDA Recall D-0356-2021
Teligent Pharma, Inc. · Buena, NJ
Class II Ongoing 1861 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Reason for recall
Failed Impurities/Degradation Specifications:
Recall record
- Recall number
D-0356-2021- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Distributed Nationwide in the USA
- Recall initiated
- 2021-04-09
- Classified by FDA Center
- 2021-04-28
- FDA published
- 2021-04-28
- Recalling firm
- Teligent Pharma, Inc.
- Firm location
- Buena, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.