Recalls / Class III
Class IIID-0064-2021
Product
Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
- Affected lot / code info
- Lot#: a) 12250, Exp 10/2020; 15039, Exp 1/2022; 15573, Exp 7/2022; b) 12250, Exp 10/2020; 14589, 14848, Exp 12/2021; 15039, Exp 1/2022; 15245, Exp 2/2022; c) 12241, 12249, Exp 10/2020; 14222, Exp 8/2021; 15039, Exp 1/2022; 15037, 15246, Exp 2/2022; 15340, Exp 3/2022; 15387, Exp 4/2022
Why it was recalled
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
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
- 36,790 tubes
- Distribution pattern
- United States Nationwide
Timeline
- Recall initiated
- 2020-09-28
- FDA classified
- 2020-11-05
- Posted by FDA
- 2020-11-11
- Terminated
- 2022-08-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0064-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.