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Teligent Pharma, Inc.

FDA Regulatory Profile

Summary

Total Recalls
63 (3 Class I)
510(k) Clearances
0
Inspections
8
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0677-2022Class IIDesoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tuMarch 15, 2022
D-0693-2022Class IILidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tuMarch 15, 2022
D-0692-2022Class IIHydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4March 15, 2022
D-0682-2022Class IIEconazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDCMarch 15, 2022
D-0679-2022Class IIDiclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent PharmMarch 15, 2022
D-0687-2022Class IIGentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tuMarch 15, 2022
D-0669-2022Class IIBetamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, March 15, 2022
D-0694-2022Class IILidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, NMarch 15, 2022
D-0703-2022Class IIHydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA PharmMarch 15, 2022
D-0699-2022Class IITriamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 gMarch 15, 2022
D-0670-2022Class IIClobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams March 15, 2022
D-0671-2022Class IIClobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; March 15, 2022
D-0698-2022Class IITriamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc.,March 15, 2022
D-0674-2022Class IIClobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, March 15, 2022
D-0691-2022Class IIHalobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent PhMarch 15, 2022
D-0690-2022Class IIHydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne PharmMarch 15, 2022
D-0700-2022Class IIClobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA PhMarch 15, 2022
D-0686-2022Class IIGentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC March 15, 2022
D-0685-2022Class IIFluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bMarch 15, 2022
D-0676-2022Class IIDesoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA PharmacMarch 15, 2022