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
Reported: November 11, 2020 Initiated: September 28, 2020 #D-0064-2021
Product Description
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
Reason for Recall
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Details
- Recalling Firm
- Teligent Pharma, Inc.
- Units Affected
- 36,790 tubes
- Distribution
- United States Nationwide
- Location
- Buena, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teligent Pharma, Inc.. Units affected: 36,790 tubes.
Why was this product recalled? ▼
Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 11, 2020. Severity: Low. Recall number: D-0064-2021.
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