FDA (Drugs) recall action 89798

Teligent Pharma, Inc. recalled 37 products on 2022-03-30

The FDA (Drugs) publishes a recall like this one as 37 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 37 pages.

Products: 37
Announced: 2022-03-30
Critical: 0
Units: 2,508,931

Why these products were recalled

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 37

ModerateFDA (Drugs)··2022-03-30
Desoximetasone Ointment USP Recalled by Teligent Pharma
Teligent Pharma is recalling Desoximetasone Ointment USP 0.25% in all sizes nationwide due to cGMP deviations related to discontinuation of the stability study program.
Product
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, New Jersey 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Gentamicin Sulfate Cream Recalled Due to Manufacturing Practice Violations
Teligent Pharma, Inc. is recalling 31,489 tubes of Gentamicin Sulfate Cream (0.1%) nationwide due to manufacturing violations. The company discontinued its stability testing program without proper authorization.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Desoximetasone Ointment USP 0.05% Recalled Due to cGMP Deviations
Teligent Pharma is recalling Desoximetasone Ointment USP 0.05% nationwide due to current good manufacturing practice (cGMP) deviations. The firm is discontinuing its stability study program, affecting all products within expiry.
Product
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-037-10.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Lidocaine Cream 4% Recalled Due to Manufacturing Quality Deviations
Teligent Pharma is recalling all unexpired batches of Lidocaine Cream 4% (30-gram tubes) nationwide because the company is discontinuing its stability study program, a violation of manufacturing standards.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Triamcinolone Acetonide Cream USP 0.1% Recall — Stability Study Discontinuation
Teligent Pharma is recalling all unexpired Triamcinolone Acetonide Cream USP 0.1% nationwide due to discontinuation of its stability study program, which creates a cGMP deviation. The company has recalled approximately 721,225 tubes and 90,893 jars distributed across multiple package sizes.
Product
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 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Clobetasol Propionate Ointment USP 0.05% Nationwide Recall
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Ointment USP 0.05% nationwide because the manufacturer is discontinuing its stability study program, raising questions about product integrity.
Product
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, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Lidocaine Ointment USP 5% Recalled Due to cGMP Deviations
Teligent Pharma, Inc. is recalling all unexpired batches of Lidocaine Ointment USP, 5% nationwide and in Puerto Rico because the manufacturer is discontinuing its stability study program, a violation of good manufacturing practices.
Product
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.
Category
Distribution
1 state
HighFDA (Drugs)··2022-03-30
Fluocinonide Cream Recalled for Manufacturing Compliance and Stability Deviations
Teligent Pharma, Inc. is recalling Fluocinonide Cream USP 0.1% due to manufacturing compliance deviations and discontinuation of stability studies. The recall affects products nationwide in the USA and Puerto Rico.
Product
Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Econazole Nitrate Cream Recalled Due to Manufacturing Process Deviations
Teligent Pharma is recalling Econazole Nitrate Cream, 1% due to current Good Manufacturing Practice deviations related to discontinued stability studies. Approximately 151,975 tubes distributed nationwide are affected.
Product
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., Buena, New Jersey 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Hydrocortisone Butyrate Lotion recalled due to cGMP deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% (4 fl. oz. bottles) nationwide because the manufacturer discontinued its stability study program, which is a deviation from good manufacturing practice standards.
Product
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Fluocinonide Gel Recalled for Manufacturing Process Deviations
Teligent Pharma, Inc. is recalling all Fluocinonide Gel USP 0.05% nationwide within expiration date due to manufacturing deviations related to discontinued stability studies.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Clobetasol Propionate Cream USP 0.05% Recall for cGMP Deviations
Teligent Pharma is recalling all unexpired Clobetasol Propionate Cream USP 0.05% nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the firm's stability study program.
Product
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 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Diclofenac Sodium Topical Solution Recalled for Manufacturing Compliance Deviations
Teligent Pharma recalled 36,018 bottles of Diclofenac Sodium Topical Solution nationwide due to cGMP deviations related to discontinued stability studies, affecting all batches through May 2024.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Desonide Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Desonide Ointment 0.05% nationwide because the manufacturer is discontinuing its stability study program, a deviation from current good manufacturing practices (cGMP).
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Nystatin and Triamcinolone Acetonide Ointment Recall Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Nystatin and Triamcinolone Acetonide Ointment (15g, 30g, and 60g tubes) nationwide due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.
Product
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: Teligent Pharma, Inc., Buena, NJ 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Gentamicin Sulfate Ointment Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Gentamicin Sulfate Ointment USP 0.1% due to cGMP deviations related to discontinuation of the firm's stability study program.
Product
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.
Category
Distribution
1 state
HighFDA (Drugs)··2022-03-30
FDA Recalls Betamethasone Dipropionate Lotion Due to Manufacturing Deviations
Teligent Pharma is recalling Betamethasone Dipropionate Lotion due to manufacturing practice deviations and discontinuation of the stability study program. The recall affects 43,218 bottles distributed nationwide.
Product
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., Buena, NJ 08310
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Desoximetasone Ointment USP 0.05% Recall Due to cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Desoximetasone Ointment USP 0.05% (54,897 tubes) distributed nationwide because the manufacturer is discontinuing its stability study program, a violation of current good manufacturing practices.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Hydrocortisone Butyrate Lotion Recalled Due to cGMP Deviations
Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% nationwide due to cGMP deviations. The firm discontinued its stability study program, prompting recall of all products within expiry.
Product
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, NJ 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Halobetasol Propionate Ointment Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired Halobetasol Propionate Ointment 0.05% due to current Good Manufacturing Practice (cGMP) deviations. The firm has discontinued its stability study program.
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Clobetasol Propionate Gel Recalled Due to Manufacturing Deviations
Teligent Pharma is recalling all unexpired batches of Clobetasol Propionate Gel 0.05% due to deviations from good manufacturing practices. The firm discontinued its stability study program, prompting the recall of 81,883 tubes distributed nationwide and in Puerto Rico.
Product
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 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Clobetasol Propionate Lotion recall due to manufacturing deviations
Teligent Pharma is recalling 35,180 bottles of Clobetasol Propionate Lotion 0.05% nationwide due to manufacturing deviations and discontinued stability testing. No illnesses reported.
Product
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, New Jersey 08310.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Triamcinolone Acetonide Lotion Recalled for cGMP Deviations
Teligent Pharma is recalling all unexpired batches of Triamcinolone Acetonide Lotion USP 0.025% due to current Good Manufacturing Practice (cGMP) deviations related to discontinuation of the stability study program.
Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Diflorasone Diacetate Ointment USP 0.05% Nationwide Recall
Teligent Pharma is recalling all unexpired batches of Diflorasone Diacetate Ointment USP 0.05% nationwide due to cGMP deviations related to discontinuation of the stability study program.
Product
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.
Category
Distribution
1 state