Recall: D-1173-2022

Class III - Minor Violations

Class IIIClassification

2022-06-16Initiated

TerminatedStatus

Glenmark Pharmaceuticals Inc.,Firm

Product

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.

Reason

Defective Container

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.