Buena, NJ, United States
Teligent Pharma, Inc. recalls
19 recalls recorded since 2018, most recently on 15 March 2022. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls19
Ongoing (FDA)4
Terminated or completed15
Class I (FDA)3
Terminated Class II Drugs
- Recall started
- 15 March 2022
- Terminated
- 17 June 2024
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Distribution
- Nationwide in the USA and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0696-2022, D-0678-2022, D-0697-2022, D-0705-2022, D-0675-2022, D-0694-2022, D-0687-2022, D-0699-2022, D-0688-2022, D-0670-2022, D-0703-2022, D-0686-2022 and 25 more
- Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-048-15.
- 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.
- 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, Teligen
- 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.
- 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.
- 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.
- 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.
- 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., Buena, New Jersey
- and 29 more product lines
Terminated Class II Drugs
- Recall started
- 7 February 2022
- Terminated
- 9 May 2024
- Reason
- Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
- Distribution
- Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0716-2022
- 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., Suite 101, Memphis, TN
Ongoing Class I, Class II Drugs
- Recall started
- 30 November 2021
- Reason
- Superpotent Drug: Minimally superpotent
- Distribution
- Distributed to a wholesaler in CO who further distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0296-2022, D-0295-2022
- 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 dba Sky Packaging,
- 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 dba Sky Packaging,
Terminated Class II Drugs
- Recall started
- 19 October 2021
- Terminated
- 18 June 2024
- Reason
- Defective Container
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0259-2022, D-0258-2022
- 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.
- 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
Terminated Class I, Class II Drugs
- Recall started
- 12 October 2021
- Terminated
- 18 June 2024
- Reason
- Superpotent Drug
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0280-2022, D-0281-2022, D-0279-2022
- 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
- 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
- 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, 497 Southridge Blv
Terminated Class II Drugs
- Recall started
- 23 August 2021
- Terminated
- 16 August 2024
- Reason
- Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0297-2022
- Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
Ongoing Class I Drugs
- Recall started
- 3 August 2021
- Reason
- Superpotent Drug
- Distribution
- Nationwide within the United States and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0800-2021
- Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
Terminated Class III Drugs
- Recall started
- 29 July 2021
- Terminated
- 15 August 2024
- Reason
- Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0785-2021
- 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.
Ongoing Class II Drugs
- Recall started
- 29 July 2021
- Reason
- Defective container: possibility for lack of seal integrity.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0769-2021
- Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Terminated Class II Drugs
- Recall started
- 19 July 2021
- Terminated
- 16 August 2024
- Reason
- Correct Labeled Product Mispack
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0752-2021, D-0751-2021
- 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.
- Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
Terminated Class III Drugs
- Recall started
- 22 June 2021
- Terminated
- 3 July 2024
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0690-2021, D-0689-2021
- Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,
- Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Terminated Class II Drugs
- Recall started
- 14 May 2021
- Terminated
- 22 August 2022
- Reason
- Presence of Foreign Substance: Foreign particles observed during routine stability testing.
- Distribution
- Nationwide in the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0636-2021
- Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, Rx only, Manufactured by: Teligent Pharma, Inc, Buena, NJ 08310.
Ongoing Class II Drugs
- Recall started
- 9 April 2021
- Reason
- Failed Impurities/Degradation Specifications:
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0356-2021
- Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
Terminated Class III Drugs
- Recall started
- 29 March 2021
- Terminated
- 3 July 2024
- Reason
- Failed Stability Specifications: product did not meet viscosity results.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0331-2021
- 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.
Terminated Class III Drugs
- Recall started
- 2 February 2021
- Terminated
- 15 August 2024
- Reason
- Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0338-2021, D-0340-2021, D-0339-2021
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbri
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
Terminated Class III Drugs
- Recall started
- 5 November 2020
- Terminated
- 16 August 2024
- Reason
- Superpotent and Subpotent; low and high assay results
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0119-2021
- Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
Terminated Class III Drugs
- Recall started
- 3 November 2020
- Terminated
- 21 December 2023
- Reason
- Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0110-2021
- Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
Terminated Class III Drugs
- Recall started
- 28 September 2020
- Terminated
- 22 August 2022
- Reason
- Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
- Distribution
- United States Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0064-2021
- Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 083
Terminated Class III Drugs
- Recall started
- 20 May 2019
- Terminated
- 27 January 2025
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1391-2019
- Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.