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

26–37 of 37

ModerateFDA (Drugs)··2022-03-30
Gentamicin Sulfate Cream USP 0.1% Recalled for cGMP Deviations
Teligent Pharma is recalling Gentamicin Sulfate Cream USP 0.1% distributed nationwide because the manufacturer is discontinuing its stability study program, which represents a deviation from FDA good manufacturing practices (cGMP).
Product
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.
Category
Distribution
1 state
ModerateFDA (Drugs)··2022-03-30
Lidocaine Cream 4% Recalled Due to cGMP Deviations
Teligent Pharma is recalling all unexpired Lidocaine Cream 4% due to manufacturing quality deviations. The firm has discontinued its stability study program.
Product
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. Buena, New Jersey 08310; Manufactured by: Teligent Pharma, Inc., Buena, New Jer
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
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
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
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
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
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
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
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
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
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