fda
63 records
FDA Drug Recall: Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teli
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-03
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 5256
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufacture
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g t
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Ph
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-09
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 5
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufact
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufact
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15,
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b)
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Te
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 1
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactu
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufact
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, ND
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-04
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tube
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactur
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distrib
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manu
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 525
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, N
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactu
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 5256
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b)
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufac
2022-03-30
Class II — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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FDA Drug Recall: Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Te
2022-02-23
Class II — Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
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FDA Drug Recall: Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g),
2022-01-05
Class II — Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
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FDA Drug Recall: Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL
2022-01-05
Class II — Superpotent Drug: Minimally superpotent
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FDA Drug Recall: Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL
2022-01-05
Class I — Superpotent Drug
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FDA Drug Recall: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles,
2021-12-22
Class I — Superpotent Drug
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FDA Drug Recall: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles,
2021-12-22
Class II — 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...
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FDA Drug Recall: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles,
2021-12-22
Class II — 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...
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FDA Drug Recall: Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottle
2021-12-01
Class II — Defective Container
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FDA Drug Recall: Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottle
2021-12-01
Class II — Defective Container
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FDA Drug Recall: Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only
2021-09-22
Class I — Superpotent Drug
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FDA Drug Recall: Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a lamina
2021-09-08
Class III — Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
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FDA Drug Recall: Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, In
2021-09-01
Class II — Defective container: possibility for lack of seal integrity.
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FDA Drug Recall: Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Phar
2021-08-25
Class II — Correct Labeled Product Mispack
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FDA Drug Recall: Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, I
2021-08-25
Class II — Correct Labeled Product Mispack
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FDA Drug Recall: Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC
2021-07-28
Class III — Failed Impurities/Degradation Specifications
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FDA Drug Recall: Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Bu
2021-07-28
Class III — Failed Impurities/Degradation Specifications
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FDA Drug Recall: Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15)
2021-06-30
Class II — Presence of Foreign Substance: Foreign particles observed during routine stability testing.
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FDA Drug Recall: Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gram
2021-05-05
Class III — Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
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FDA Drug Recall: Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams
2021-05-05
Class III — Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
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FDA Drug Recall: Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams
2021-05-05
Class III — Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
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FDA Drug Recall: Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma
2021-04-28
Class II — Failed Impurities/Degradation Specifications:
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FDA Drug Recall: Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Ph
2021-04-21
Class III — Failed Stability Specifications: product did not meet viscosity results.
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FDA Drug Recall: Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Ph
2020-12-09
Class III — Superpotent and Subpotent; low and high assay results
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FDA Drug Recall: Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Te
2020-12-02
Class III — Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
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FDA Drug Recall: Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15,
2020-11-11
Class III — Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
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FDA Drug Recall: Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 525
2019-06-26
Class III — Failed Impurities/Degradation Specifications
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ny_corps
1 records
NY Corp: TELIGENT PHARMA, INC.
2015-11-13
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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