Recall Enforment Report D-0824-2021

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Glenmark Pharmaceuticals Inc., USA, originally initiated on 08-27-2021 for the product Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 The product was recalled due to cgmp deviations. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0824-2021	08-27-2021	09-29-2021	Class II	4752 bottles	Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430	CGMP Deviations	Terminated
D-0826-2021	08-27-2021	09-29-2021	Class II	a) 216,454 bottles; b) 2166 bottles	Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05	CGMP Deviations	Terminated
D-0827-2021	08-27-2021	09-29-2021	Class II	a) 5362 inhalers; b) 5593 inhalers	Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35	Lack of Assurance of Sterility	Terminated
D-0825-2021	08-27-2021	09-29-2021	Class II	15936 bottles	Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430	CGMP Deviations	Terminated
D-0820-2021	08-27-2021	09-29-2021	Class II	28658 cartons	Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32	Lack of Assurance of Sterility	Terminated
D-0823-2021	08-27-2021	09-29-2021	Class II	1800 bottles	Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430	CGMP Deviations	Terminated
D-0821-2021	08-27-2021	09-29-2021	Class II	9552 bottles	Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430	CGMP Deviations	Terminated
D-0822-2021	08-27-2021	09-29-2021	Class II	a) 31248 bottles; b) 300 bottles	Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05	CGMP Deviations	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
68462-128	Zonisamide	Zonisamide	Capsule	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-129	Zonisamide	Zonisamide	Capsule	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-130	Zonisamide	Zonisamide	Capsule	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-178	Naproxen Sodium	Naproxen Sodium	Tablet	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-179	Naproxen Sodium	Naproxen Sodium	Tablet	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-188	Naproxen	Naproxen	Tablet	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-189	Naproxen	Naproxen	Tablet	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-190	Naproxen	Naproxen	Tablet	Oral	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug
68462-317	Fulvestrant	Fulvestrant	Injection	Intramuscular	Glenmark Pharmaceuticals Inc., Usa	Human Prescription Drug

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0824-2021 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. 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	Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason For Recall	CGMP Deviations What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4752 bottles 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: 29200023 Exp. 03/31/2022; 29200025 Exp. 03/31/2022; 29200036 Exp. 06/30/2022; 29200056 Exp. 09/30/2022; 29200070 Exp. 11/30/2022 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.
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.

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0826-2021 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. 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	Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Reason For Recall	CGMP Deviations What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 216,454 bottles; b) 2166 bottles 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023 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	68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05
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.

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0827-2021 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. 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	Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 5362 inhalers; b) 5593 inhalers 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: a) 30210041 Exp. 03/31/2023; 30210045 Exp. 04/30/2023; 30210046 Exp. 04/30/2023; 30210050 Exp. 03/31/2023; 30210051 Exp. 04/30/2023; 30210058 Exp. 04/30/2023; b) 30210042 Exp. 03/31/2023; 30210047 Exp. 04/30/2023; 30210048 Exp. 04/30/2023; 30210052 Exp. 04/30/2023; 30210053 Exp. 04/30/2023; 30210054 Exp. 04/30/2023; 30210059 Exp. 04/30/2023; 30210060 Exp. 04/30/2023; 30210061 Exp. 04/30/2023; 30210062 Exp. 04/30/2023; 30210063 Exp. 04/30/2023; 30210064 Exp. 05/31/2023 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.
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.

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0825-2021 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. 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	Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason For Recall	CGMP Deviations What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	15936 bottles 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022 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	68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05
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.

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0820-2021 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. 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	Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Reason For Recall	Lack of Assurance of Sterility What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	28658 cartons 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022; 30210002 Exp. 12/31/2022; 30210003 Exp. 01/31/2023; 30210004 Exp. 01/31/2023; 30210005 Exp. 01/31/2023; 30210006 Exp. 01/31/2023; 30210014 Exp. 02/28/2023; 30210022 Exp. 02/28/2023; 30210028 Exp. 02/28/2023; 30210029 Exp. 02/28/2023; 30210030 Exp. 02/28/2023; 30210031 Exp. 02/28/2023 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	68462-317-32
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.

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0823-2021 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. 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	Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason For Recall	CGMP Deviations What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1800 bottles 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: 29200022 Exp. 03/31/2022; 29200024 Exp. 03/31/2022; 29200035 Exp. 06/30/2022 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.
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.

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0821-2021 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. 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	Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason For Recall	CGMP Deviations What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	9552 bottles 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: 29190087 Exp. 10/31/2021; 29190088 Exp. 10/31/2021; 29190089 Exp. 10/31/2021; 29200077 Exp. 11/30/2022; 29200078 Exo, 11/30/2022 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	68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05
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.

Field Name	Field Value
Event ID	88591 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0822-2021 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. 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	Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Reason For Recall	CGMP Deviations What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 31248 bottles; b) 300 bottles 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	09-29-2021
Recall Initiation Date	08-27-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-04-2023 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	Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022 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	68462-188-01; 68462-188-05; 68462-189-01; 68462-189-05; 68462-190-30; 68462-190-50; 68462-190-01; 68462-190-05; 68462-178-01; 68462-178-05; 68462-179-01; 68462-179-05
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.