Teligent Pharma recalls
Teligent Pharma appears in 63 official U.S. recall notices indexed by RecallRadar, most recently on 2022-03-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 63 |
|---|---|
| Published | 2019-06-26 to 2022-03-30 |
| By agency | FDA Drug (63) |
| By classification | Class II (49), Class III (11), Class I (3) |
| By status | terminated (58), ongoing (5) |
| Distribution named in notices | US |
Recalls
- Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - 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:…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - 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 5…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge,…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, N…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distribute…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - 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
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - 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, N…
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02
FDA Drug · Class II · 2022-03-30 · Teligent Pharma
Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKes…
FDA Drug · Class II · 2022-02-23 · Teligent Pharma
Reason: Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds. - Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma…
FDA Drug · Class I · 2022-01-05 · Teligent Pharma
Reason: Superpotent Drug - Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma…
FDA Drug · Class II · 2022-01-05 · Teligent Pharma
Reason: Superpotent Drug: Minimally superpotent - Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-…
FDA Drug · Class II · 2022-01-05 · Teligent Pharma
Reason: Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing - Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-…
FDA Drug · Class I · 2021-12-22 · Teligent Pharma
Reason: Superpotent Drug - Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-…
FDA Drug · Class II · 2021-12-22 · Teligent Pharma
Reason: CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent. - Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ…
FDA Drug · Class II · 2021-12-22 · Teligent Pharma
Reason: CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent. - 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…
FDA Drug · Class II · 2021-12-01 · Teligent Pharma
Reason: Defective Container - 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…
FDA Drug · Class II · 2021-12-01 · Teligent Pharma
Reason: Defective Container - Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc
FDA Drug · Class I · 2021-09-22 · Teligent Pharma
Reason: Superpotent Drug - Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc
FDA Drug · Class III · 2021-09-08 · Teligent Pharma
Reason: Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing. - Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc
FDA Drug · Class II · 2021-09-01 · Teligent Pharma
Reason: Defective container: possibility for lack of seal integrity. - Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc
FDA Drug · Class II · 2021-08-25 · Teligent Pharma
Reason: Correct Labeled Product Mispack