Class III
Terminated
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
This recall has been terminated (originally issued November 11, 2020).
- Company
- Teligent Pharma, Inc.
- Recall Initiated
- September 28, 2020
- Posted
- November 11, 2020
- Recall Number
- D-0064-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 36,790 tubes
- Firm Location
- Buena, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Distribution
United States Nationwide
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
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