Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tube... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Ph... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc.... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 g... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, In... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 8... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent ... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA P... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Ph... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Pa... Mar 15, 2022 FDA drug enforcement
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II Reported terminated
Distribution: Nationwide in the USA and Puerto Rico
Official source for Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Ph... Feb 7, 2022 FDA drug enforcement
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
Class II Reported terminated
Distribution: Nationwide in the USA.
Official source for Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, In... Nov 30, 2021 FDA drug enforcement
Superpotent Drug
Class I Reported ongoing
Distribution: Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Official source for Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles... Nov 30, 2021 FDA drug enforcement
Superpotent Drug: Minimally superpotent
Class II Reported ongoing
Distribution: Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Official source for Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles...