Recall Enforment Report D-0521-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Preferred Pharmaceuticals, Inc., originally initiated on 03-23-2023 for the product Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9 The product was recalled due to cgmp deviations for the manufacturing firm (accord healthcare) after their inspection.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0521-2023	03-23-2023	04-12-2023	Class II	24 Bottles	Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0514-2023	03-23-2023	04-12-2023	Class II	3 Bottles	Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0515-2023	03-23-2023	04-12-2023	Class II	4 Bottles	Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0519-2023	03-23-2023	04-12-2023	Class II	a) 59 Bottles, b) 77 Bottles	Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0517-2023	03-23-2023	04-12-2023	Class II	17 Bottles	Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0527-2023	03-23-2023	04-12-2023	Class II	15 Bottles	Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0524-2023	03-23-2023	04-12-2023	Class II	a) 305 Bottles, b) 72 Bottles, c) 617 Bottles	Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0523-2023	03-23-2023	04-12-2023	Class II	57 Bottles	Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0518-2023	03-23-2023	04-12-2023	Class II	a) 266 Bottles, b) not reported, c) 216 Bottles	Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0520-2023	03-23-2023	04-12-2023	Class II	264 Bottles	Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0526-2023	03-23-2023	04-12-2023	Class II	32 Bottles	Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0522-2023	03-23-2023	04-12-2023	Class II	82 Bottles of 90 Tablets	Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0525-2023	03-23-2023	04-12-2023	Class II	a) 88 Bottles, b) 3 Bottles, c) 175 Bottles	Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0511-2023	03-23-2023	04-12-2023	Class II	158 Bottles	Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0516-2023	03-23-2023	04-12-2023	Class II	a) 135 Bottles, b) 24 Bottles	Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0512-2023	03-23-2023	04-12-2023	Class II	a) 375 Bottles b) 323 Bottles	Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing
D-0513-2023	03-23-2023	04-12-2023	Class II	72 Bottles	Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
68788-6976	Finasteride	Finasteride	Tablet, Film Coated	Oral	Preferred Pharmacetucals Inc.	Human Prescription Drug
68788-7086	Rosuvastatin Calcium	Rosuvastatin Calcium	Tablet, Film Coated	Oral	Preferred Pharmaceuticals Inc.	Human Prescription Drug
68788-7971	Rosuvastatin	Rosuvastatin	Tablet, Film Coated	Oral	Preferred Pharmaceuticals Inc.	Human Prescription Drug
68788-8066	Glimepiride	Glimepiride	Tablet	Oral	Preferred Pharmaceuticals Inc.	Human Prescription Drug
68788-8095	Glimepiride	Glimepiride	Tablet	Oral	Preferred Pharmaceuticals Inc.	Human Prescription Drug
68788-8153	Tadalafil	Tadalafil	Tablet, Film Coated	Oral	Preferred Pharmaceuticals Inc.	Human Prescription Drug
68788-9429	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Preferred Pharmaceuticals, Inc.	Human Prescription Drug
68788-9438	Montelukast Sodium	Montelukast Sodium	Tablet, Film Coated	Oral	Preferred Pharmaceuticals Inc.	Human Prescription Drug
68788-9747	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Preferred Pharmaceuticals, Inc.	Human Prescription Drug
68788-9868	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Preferred Pharmaceuticals, Inc.	Human Prescription Drug
68788-9869	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Preferred Pharmaceuticals, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0521-2023 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	USA 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	Pravastatin Sodium Tablets, USP, 20 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8215-9
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	24 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: F1021I; H3122J, Exp 4/30/2024 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	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0514-2023 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	USA 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	Doxazosin Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7328-1
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	3 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: H3122K, Exp 5/31/2024. 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	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0515-2023 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	USA 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	Doxazosin Tablets, USP, 4 mg, 100-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7149-1
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: L1522V, Exp 4/30/2025. 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	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0519-2023 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	USA 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	Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) 30-count bottle (NDC 68788-7086-3); b) 90-count bottle (NDC 68788-7086-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 59 Bottles, b) 77 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	a) Lot: F2022N, Exp. Date: 2/29/2024; b) Lot: F0322I, Exp. Date: 8/31/2023; Lot: J1322H, Exp. Date: 2/29/2024; Lot: K0222N, Exp. Date: 6/30/2024; Lot: L2322D and Lot: L2822J, Exp. Date:7/31/2025. 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	68788-7086-2; 68788-7086-3; 68788-7086-6; 68788-7086-9
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0517-2023 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	USA 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	Glimepiride Tablets, USP, 2 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8095-9
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	17 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: D0122K, Exp. Date: 6/30/2024; Lot: I1422N, Exp. Date: 9/30/2024; Lot: I2721B, Exp. Date: 1/31/2024. 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	68788-8095-3; 68788-8095-6; 68788-8095-9; 68788-8095-1
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0527-2023 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	USA 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	Glimepiride Tablets USP, 4 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8066-9
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	15 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: H1221Z, I0121J, J0622X, Exp 10/31/2023. 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	68788-8066-3; 68788-8066-6; 68788-8066-9
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0524-2023 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	USA 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	Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 305 Bottles, b) 72 Bottles, c) 617 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	a) Lot: A0923R, Exp. Date: 2/28/2025, A1222K, B1822C, Exp. Date: 5/31/2024, C3022D, F2322V, Exp. Date: 6/30/2024, H1522H, Exp. Date: 8/31/2024, I1621O, Exp. Date: 1/31/2024, I2222G, J1822R, Exp. Date: 9/30/2024, L1621N, Exp. Date: 5/31/2024; b) Lot: F0822Q, Exp. Date: 6/30/2024, I0122J, Exp. Date: 8/31/2024, L0821C, Exp. Date: 5/31/2024; c) Lot: I1521P, Exp. Date: 1/31/2024, J1322R, Exp. Date: 9/30/2024, J1821H, Exp. Date: 2/29/2024. 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	68788-9747-3; 68788-9747-6; 68788-9747-9; 68788-9747-1; 68788-9869-3; 68788-9869-6; 68788-9869-9; 68788-9869-1; 68788-9868-3; 68788-9868-6; 68788-9868-9; 68788-9868-1; 68788-9429-3; 68788-9429-6; 68788-9429-9; 68788-9429-1
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0523-2023 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	USA 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	Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	57 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: B0222S, Exp 2/29/2024; Lot: F1121B, G2721L, Exp 11/30/2023. 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	68788-9747-3; 68788-9747-6; 68788-9747-9; 68788-9747-1; 68788-9869-3; 68788-9869-6; 68788-9869-9; 68788-9869-1; 68788-9868-3; 68788-9868-6; 68788-9868-9; 68788-9868-1; 68788-9429-3; 68788-9429-6; 68788-9429-9; 68788-9429-1
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0518-2023 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	USA 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	Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 266 Bottles, b) not reported, c) 216 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	a) Lot: F3021D, Exp 12/31/2023, Lot: L0722T, Exp 5/31/2025; b) Lot: F1021I, Exp 12/31/2023; c) Lot:H1721R, Exp 12/31/2023, Lot: L0722E, Exp 5/31/2025. 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	68788-9438-1; 68788-9438-4; 68788-9438-2; 68788-9438-3; 68788-9438-6; 68788-9438-9
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0520-2023 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	USA 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	Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	264 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: A1723C, Exp 8/31/2025; Lot: A1922B, Exp 6/30/2024; Lot: D0622M and Lot: F2922I, Exp 7/31/2024; Lot: G3021L, Exp 1/31/2024; Lot:H2622P & Lot: J0722C, Exp 10/31/2024. 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	68788-7971-3; 68788-7971-6; 68788-7971-9
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0526-2023 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	USA 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	Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	32 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: C0822E, Exp 1/31/2024, F1121B, Exp 1/31/2024, G2721L, Exp 1/31/2024. 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	68788-8153-7
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0522-2023 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	USA 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	Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9747-9
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	82 Bottles of 90 Tablets 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: C2222P, D1522L, E3122D, G2522J, Exp 9/30/2023; Lot: J1222R, Exp 10/31/2023. 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	68788-9747-3; 68788-9747-6; 68788-9747-9; 68788-9747-1; 68788-9869-3; 68788-9869-6; 68788-9869-9; 68788-9869-1; 68788-9868-3; 68788-9868-6; 68788-9868-9; 68788-9868-1; 68788-9429-3; 68788-9429-6; 68788-9429-9; 68788-9429-1
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0525-2023 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	USA 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	Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 88 Bottles, b) 3 Bottles, c) 175 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	a) Lot: B0922G, Exp. Date: 5/31/2023, F0322G, Exp. Date: 7/25/2024, H2622M, Exp. Date: 8/31/2024, J1422B, K0722G, Exp. Date: 10/31/2024, L1922A, Exp. Date: 2/28/2025; b) Lot: F2922S, Exp. Date: 8/31/2023, H0322G Exp. Date: 7/31/2023; c) Lot: A1322I, Exp. Date: 3/31/2023, H1122C, Exp. Date: 8/31/2024. 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	68788-9747-3; 68788-9747-6; 68788-9747-9; 68788-9747-1; 68788-9869-3; 68788-9869-6; 68788-9869-9; 68788-9869-1; 68788-9868-3; 68788-9868-6; 68788-9868-9; 68788-9868-1; 68788-9429-3; 68788-9429-6; 68788-9429-9; 68788-9429-1
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0511-2023 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	USA 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	Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	158 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot #: A0523D, Exp 5/31/2024, F14220, Exp 7/31/2023, J0622Q; Exp 1/31/2024. 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	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0516-2023 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	USA 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	Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 135 Bottles, b) 24 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	a) Lot: A1321V, D0221J, Exp. Date:8/31/2023; Lot: A1322J, Exp. Date: 5/31/2024; Lot: F0221Q, I0121E, I1021R, J1122D, Exp. Date: 10/31/2023; b) Lot: B0422J, Exp. Date: 5/31/2024; Lot: C1721K, Exp. Date: 8/31/2023; Lot: K1022Q, Exp. Date:11/30/2024. 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	68788-6976-3; 68788-6976-6; 68788-6976-9; 68788-6976-1
Status	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0512-2023 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	USA 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	Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 375 Bottles b) 323 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	a) Lot: B1522B, Exp 4/30/2023; lot:C0222H, C0322B, Exp 5/31/2023; lot: E1022H, F13220, H2222P, Exp 6/30/2023; Lot: I1422V, K01220, Exp 12/31/2023; Lot: L2722H, Exp 3/31/2024; b) Lot:C0322B, Exp 5/31/2023; lot:H1122G, 12322Q, Exp 6/30/2023; lot: J1222U, Exp 12/31/2023. 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	Ongoing

Field Name	Field Value
Event ID	91952 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0513-2023 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	USA 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	Clopidogrel Tablets USP, 75 mg, 90-count bottles, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-8190-9
Reason For Recall	cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	72 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	04-12-2023
Recall Initiation Date	03-23-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of 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	Preferred Pharmaceuticals, Inc.
Code Info	Lot: E0922W, G1222E, I0922W and K3022W Exp 10/31/2023. 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	Ongoing