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FDA (Drug enforcement)Recalled 2022-06-16closedclass iii

Glenmark Pharmaceuticals Inc., USA: Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark P

Is my product affected?

Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.

  • Brand MOMETASONE FUROATE

Check against the official notice below — it lists the full affected range.

What happened

Glenmark Pharmaceuticals Inc., USA is recalling Mometasone Furoate Topical Solution USP, 0.1% Lotion in 30 ml and 60 ml bottles due to defective containers. The recall affects 98,307 packs distributed nationwide and includes multiple lot numbers with expiration dates ranging from June 2022 through October 2023.

The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Defective Container

Details from the source

Reason for recall: Defective Container Distribution: Nationwide in the USA Quantity: 98, 307 packs Lot/code info: Lot # a) 05201358, Exp 06/2022; 05210287, 05210288, Exp 01/2023; 05211446, Exp 07/2023; 05211704, 05211714, Exp 08/2023; 05212217, Exp 10/2023: b) 05201358, Exp 06/2022; 05210287, 05210288, 05210424, Exp 01/2023; 05210425, 05210435, Exp 02/2023; 05211427, 05211439, 05211445, Exp 07/2023; 05211723, 05211731, 05211850, 05211864, Exp 08/2023; 05212226, 05212250, 05212261, Exp 10/2023.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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