Recall Enforment Report D-1586-2019

Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 07-23-2019 for the product Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 The product was recalled due to gmp deviations: glenmark received complaints stating that mometasone fuorate cream was gritty.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	83413 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1586-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by; Glenmark Pharmaceuticals Ltd At: Village: Kishanpura, Baddi Nalagari Road, District: Solan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason For Recall	GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	08-14-2019
Recall Initiation Date	07-23-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-26-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Glenmark Pharmaceuticals Inc., USA
Code Info	a) 05171238, 05171248, 05171249, Exp. Jul-2019; 05171582, 05171612, Exp. Aug-2019; 05171674, 05171675, 05171682, Exp. Sep 2019; 05180065, 05180066, Exp. Dec 2019; 05180264, 05180264, 05180265, 05180275, 0518276, Exp. Jan 2020; 05180411, 05180412, 05180422, Exp. Jan 2020; 05180556, 05180568 Exp..Feb-2020; 05180889, 05180890, 05180896, 05180896, 05180897 Exp. Apr 2020; 05181123, 05181129, 05181134, 05181135, Exp. May 2020; 05181415, 05181425, 05181429, 05181433, Exp. Jun 2020; 05181528, Exp. Jul 2020; 05181747, 05181748, Exp. Aug 2020. b) 05171207, 05171212, 05171213, 05171232, 05171233, Exp. Jul-2019; 05171476, 05171478, 05171479, Exp. Aug 2019; 05171596 , 05171597, 05171602, 05171603, Exp. Aug 2019; 05171683, 05171697, 05171698, 05171703, 05171718, 05171783, 05171788, 05171789, 05171790, 05171791, Exp. Sep 2019; 05180092, 05180093, 05180119, 05180219, 05180220, Exp. Dec 2019; 05180289, 05180291, 05180434,05180435, Exp. Jan-2020; 05180438, 05180439, 05180443, 05180444, 05180450, 05180462, 05180572, 05180646, Exp. Feb 2020 05180648, 05180649, 05180659, 05180660, 05180671, Mar 2020; 05180870, 05180871, 05180874, 05180877, 05180900, 05180901, Exp. Apr 2020; 05181073, 05181074, 05181086, 05181087, 05181091, 05181092, 05181101, 05181102, 05181111, 05181146, 05181147, 05181148, 05181240 Exp. May 2020; 05181241, 05181248, 05181252, 05181253, 05181257, 05181265, 05181266, 05181267, 05181272, 05181309, 05181316, 05181317, 05181332 Exp. Jun 2020; 05181588, 05181602, 05181603, 05181618, 05181619, 05181621, 05181622, 05181633, 05181634 Exp. Jul 2020; 05181754, 05181772, 05181773, 05181781 Exp. Aug 2020 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	68462-192-17; 68462-192-55
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products