Reported Nov 11, 2020 · Terminated
Fluocinonide Ointment USP 0.05%, packaged in
Teligent Pharma, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teligent Pharma, Inc. · 105 Lincoln Avenue · Buena, NJ · 08310
Is this the product you have?
Fluocinonide Ointment USP 0.05%, packaged in
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 15 gm tube, NDC 52565-0040-15 |
| 2 | 30 gm tube, NDC 52565-0040-30 |
| 3 | 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310 |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 12250, Exp 10/2020; 15039, Exp 1/2022; 15573, Exp 7/2022 2 12250, Exp 10/2020; 14589, 14848, Exp 12/2021; 15039, Exp 1/2022; 15245, Exp 2/2022 3 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 - Amount recalled
- 36,790 tubes
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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