Teligent Pharma, Inc.

Buena, NJ, United States

63

Total Recalls

3

Class I Recalls

5

Ongoing Recalls

Recalls by Teligent Pharma, Inc.

FDA Drug Class II Terminated

Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram tubes, NDC 52565-122-07; Manufactured by: Teligent Pharma, Inc.

March 15, 2022 Teligent Pharma, Inc. 136,960 tubes units
FDA Drug Class II Terminated

Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.

March 15, 2022 Teligent Pharma, Inc. 31,489 tubes units
FDA Drug Class II Terminated

Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc.,

March 15, 2022 Teligent Pharma, Inc. 151,975 tubes units
FDA Drug Class II Terminated

Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.

March 15, 2022 Teligent Pharma, Inc. 7169 bottles units
FDA Drug Class II Terminated

Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310.

March 15, 2022 Teligent Pharma, Inc. 51,748 tubes units
FDA Drug Class II Terminated

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.

March 15, 2022 Teligent Pharma, Inc. 24,304 bottles units
FDA Drug Class II Terminated

Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.

March 15, 2022 Teligent Pharma, Inc. 13,905 tubes units
FDA Drug Class II Terminated

Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.

March 15, 2022 Teligent Pharma, Inc. 36,018 bottles units
FDA Drug Class II Terminated

Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Bue

March 15, 2022 Teligent Pharma, Inc. 43,218 bottles units
FDA Drug Class II Terminated

Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena

March 15, 2022 Teligent Pharma, Inc. 35,180 bottles units
FDA Drug Class II Terminated

Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 0831

March 15, 2022 Teligent Pharma, Inc. 81,883 tubes units
FDA Drug Class II Terminated

Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 grams tube, NDC 52565-039-45; d) 60 grams tube, NDC 52565-039-60, R

March 15, 2022 Teligent Pharma, Inc. 72,826 tubes units
FDA Drug Class II Terminated

Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.

March 15, 2022 Teligent Pharma, Inc. 26,326 tubes units
FDA Drug Class II Terminated

Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

March 15, 2022 Teligent Pharma, Inc. 6431 bottles units
FDA Drug Class II Terminated

Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.

March 15, 2022 Teligent Pharma, Inc. 6850 tubes units
FDA Drug Class II Terminated

Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by:

March 15, 2022 Teligent Pharma, Inc. 217,184 tubes units
FDA Drug Class II Terminated

Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

March 15, 2022 Teligent Pharma, Inc. 54,897 tubes units
FDA Drug Class II Terminated

Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena,

March 15, 2022 Teligent Pharma, Inc. 30,497 bottles units
FDA Drug Class II Terminated

Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridg

March 15, 2022 Teligent Pharma, Inc. 21,323 tubes units
FDA Drug Class II Terminated

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.

March 15, 2022 Teligent Pharma, Inc. 4532 tubes units
FDA Drug Class II Terminated

Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05.

March 15, 2022 Teligent Pharma, Inc. 16,643 bottles units
FDA Drug Class II Terminated

Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.

March 15, 2022 Teligent Pharma, Inc. 48,907 tubes units
FDA Drug Class II Terminated

Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.

March 15, 2022 Teligent Pharma, Inc. 159,994 tubes units
FDA Drug Class II Terminated

Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, N

March 15, 2022 Teligent Pharma, Inc. 13,989 tubes units
FDA Drug Class II Terminated

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.

March 15, 2022 Teligent Pharma, Inc. 112,769 bottles units
FDA Drug Class II Terminated

Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-

March 15, 2022 Teligent Pharma, Inc. 721,225 tubes; 90,893 jars units
FDA Drug Class II Terminated

Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.

March 15, 2022 Teligent Pharma, Inc. 49,081 tubes units
FDA Drug Class II Terminated

Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

March 15, 2022 Teligent Pharma, Inc. 36,426 tubes units
FDA Drug Class II Terminated

Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-008-14.

March 15, 2022 Teligent Pharma, Inc. 100,256 tubes units
FDA Drug Class II Terminated

Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

March 15, 2022 Teligent Pharma, Inc. 43,956 tubes units
FDA Drug Class II Terminated

Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc.

March 15, 2022 Teligent Pharma, Inc. 482,003 tubes; 45,583 jars units
FDA Drug Class II Terminated

Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-

March 15, 2022 Teligent Pharma, Inc. 105,200 tubes units
FDA Drug Class II Terminated

Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-033-50.

March 15, 2022 Teligent Pharma, Inc. 35,185 tubes units
FDA Drug Class II Terminated

Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx o

March 15, 2022 Teligent Pharma, Inc. 207,933 tubes units
FDA Drug Class II Terminated

Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.

March 15, 2022 Teligent Pharma, Inc. 6874 bottles units
FDA Drug Class II Terminated

Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

March 15, 2022 Teligent Pharma, Inc. 355,672 tubes units
FDA Drug Class II Terminated

Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

March 15, 2022 Teligent Pharma, Inc. 161,331 tubes units
FDA Drug Class II Terminated

Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Su

February 7, 2022 Teligent Pharma, Inc. 11040 tubes units
FDA Drug Class II Ongoing

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation

November 30, 2021 Teligent Pharma, Inc. 7,176 bottles units
FDA Drug Class I Ongoing

Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation

November 30, 2021 Teligent Pharma, Inc. 6,816 bottles units
FDA Drug Class II Terminated

Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05

October 19, 2021 Teligent Pharma, Inc. 2664 bottles units
FDA Drug Class II Terminated

Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.

October 19, 2021 Teligent Pharma, Inc. 5400 units units
FDA Drug Class I Terminated

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

October 12, 2021 Teligent Pharma, Inc. 52,104 glass bottles units
FDA Drug Class II Terminated

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging

October 12, 2021 Teligent Pharma, Inc. 7,008 glass bottles units
FDA Drug Class II Terminated

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

October 12, 2021 Teligent Pharma, Inc. 14,664 glass bottles units
FDA Drug Class II Terminated

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

August 23, 2021 Teligent Pharma, Inc. 3,792 bottles units
FDA Drug Class I Ongoing

Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.

August 3, 2021 Teligent Pharma, Inc. 32,544 glass bottles units
FDA Drug Class III Terminated

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.

July 29, 2021 Teligent Pharma, Inc. 114,456 tubes units
FDA Drug Class II Ongoing

Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59

July 29, 2021 Teligent Pharma, Inc. 7488 bottles units
FDA Drug Class II Terminated

Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes.

July 19, 2021 Teligent Pharma, Inc. N/A units