Recall archive
23 recalls · page 1 of 1
Reported May 11, 2022
Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.McKesson Corporation dba McKesson Drug Company
Matched: Product · Product details · Reason for recall — CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability…
4 more products in this recall
FDA (openFDA drug enforcement)
Reported May 4, 2022
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teva Pharmaceuticals USA Inc.
Matched: Brand · Product details — cGMP Deviations
FDA (openFDA drug enforcement)
Reported Apr 27, 2022
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product · Product details · Reason for recall — CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability…
FDA (openFDA drug enforcement)
Reported Apr 20, 2022
Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product · Product details · Reason for recall — CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Mar 30, 2022
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product details — cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
36 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 23, 2022
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
FDA (openFDA drug enforcement)
Reported Jan 5, 2022
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teligent Pharma, Inc.
Matched: Brand · Product details — Superpotent Drug
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 22, 2021
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Dec 1, 2021
Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Defective Container
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Sep 22, 2021
Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Superpotent Drug
FDA (openFDA drug enforcement)
Reported Sep 8, 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,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
FDA (openFDA drug enforcement)
Reported Sep 1, 2021
Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Defective container: possibility for lack of seal integrity.
FDA (openFDA drug enforcement)
Reported Aug 25, 2021
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Correct Labeled Product Mispack
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 28, 2021
Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jun 30, 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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product details — Presence of Foreign Substance: Foreign particles observed during routine stability testing.
FDA (openFDA drug enforcement)
Reported May 5, 2021
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Apr 28, 2021
Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Failed Impurities/Degradation Specifications:
FDA (openFDA drug enforcement)
Reported Apr 21, 2021
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Failed Stability Specifications: product did not meet viscosity results.
FDA (openFDA drug enforcement)
Reported Dec 9, 2020
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Superpotent and Subpotent; low and high assay results
FDA (openFDA drug enforcement)
Reported Dec 2, 2020
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product · Product details — Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
FDA (openFDA drug enforcement)
Reported Nov 11, 2020
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…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity.
FDA (openFDA drug enforcement)
Reported Jun 26, 2019
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent Pharma, Inc.
Matched: Brand · Product details — Failed Impurities/Degradation Specifications
FDA (openFDA drug enforcement)
Reported May 24, 2017
Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Teligent, Inc.
Matched: Brand · Product · Product details — Superpotent Drug
FDA (openFDA drug enforcement)
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