Recalls / Class II
Class IID-0356-2021
Product
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
- Affected lot / code info
- Lot #13974 EXP 7/2021
Why it was recalled
Failed Impurities/Degradation Specifications:
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
- 3432 tubes
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-04-09
- FDA classified
- 2021-04-28
- Posted by FDA
- 2021-04-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0356-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.