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Teligent Pharma, Inc.

FDA Regulatory Profile

Teligent Pharma, Inc. has 63 FDA recalls (3 Class I), 8 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0694-2022 · Class II · Mar 15, 2022
Latest inspection
Aug 31, 2021 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls63 (3 Class I)Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections8Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0694-2022Class IILidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena…Mar 15, 2022
D-0677-2022Class IIDesoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams…Mar 15, 2022
D-0689-2022Class IIHalobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes…Mar 15, 2022
D-0684-2022Class IIFluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC…Mar 15, 2022
D-0679-2022Class IIDiclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent…Mar 15, 2022
D-0692-2022Class IIHydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4…Mar 15, 2022
D-0687-2022Class IIGentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams…Mar 15, 2022
D-0691-2022Class IIHalobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent…Mar 15, 2022
D-0700-2022Class IIClobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA…Mar 15, 2022
D-0685-2022Class IIFluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL…Mar 15, 2022
D-0674-2022Class IIClobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube…Mar 15, 2022
D-0705-2022Class IILidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech…Mar 15, 2022
D-0699-2022Class IITriamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80…Mar 15, 2022
D-0670-2022Class IIClobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams…Mar 15, 2022
D-0671-2022Class IIClobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15…Mar 15, 2022
D-0698-2022Class IITriamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc…Mar 15, 2022
D-0704-2022Class IILidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park…Mar 15, 2022
D-0701-2022Class IIDiflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent…Mar 15, 2022
D-0680-2022Class IIDiclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured…Mar 15, 2022
D-0703-2022Class IIHydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA…Mar 15, 2022

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 31, 2021Buena, NJDrugsOfficial Action Indicated (OAI)1000526875
Oct 19, 2017Buena, NJDrugsVoluntary Action Indicated (VAI)1000526875
Jan 22, 2016Buena, NJDrugsNo Action Indicated (NAI)1000526875
Dec 19, 2013Buena, NJDrugsNo Action Indicated (NAI)1000526875
Feb 2, 2012Buena, NJFood/CosmeticsNo Action Indicated (NAI)1000526875
Mar 8, 2011Buena, NJDrugsVoluntary Action Indicated (VAI)1000526875
Jul 28, 2009Buena, NJVeterinaryNo Action Indicated (NAI)1000526875
Jun 24, 2009Buena, NJDrugsNo Action Indicated (NAI)1000526875

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 1000526875Buena, NJ8Aug 31, 2021

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.