Recall Enforment Report D-1236-2020

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Aurobindo Pharma USA Inc., originally initiated on 03-18-2020 for the product Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01 The product was recalled due to cgmp deviations: products were manufactured in a processing area in which water leakage was observed. 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-1236-2020	03-18-2020	04-22-2020	Class II	2101 units	Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1231-2020	03-18-2020	04-22-2020	Class II	57337 units	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1232-2020	03-18-2020	04-22-2020	Class II	26625 units	Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1237-2020	03-18-2020	04-22-2020	Class II	14707 units	Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1230-2020	03-18-2020	04-22-2020	Class II	4332 units	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1235-2020	03-18-2020	04-22-2020	Class II	56208 units	Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1234-2020	03-18-2020	04-22-2020	Class II	26976 units	Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1233-2020	03-18-2020	04-22-2020	Class II	8040 units	Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated
D-1229-2020	03-18-2020	04-22-2020	Class II	14194 units	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
13107-001	Mirtazapine	Mirtazapine	Tablet, Film Coated	Oral	Aurolife Pharma Llc	Human Prescription Drug
13107-003	Mirtazapine	Mirtazapine	Tablet, Film Coated	Oral	Aurolife Pharma Llc	Human Prescription Drug
13107-031	Mirtazapine	Mirtazapine	Tablet, Film Coated	Oral	Aurolife Pharma Llc	Human Prescription Drug
13107-032	Mirtazapine	Mirtazapine	Tablet, Film Coated	Oral	Aurolife Pharma Llc	Human Prescription Drug
13107-043	Oxycodone And Acetaminophen	Oxycodone And Acetaminophen	Tablet	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-044	Oxycodone And Acetaminophen	Oxycodone And Acetaminophen	Tablet	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-045	Oxycodone And Acetaminophen	Oxycodone And Acetaminophen	Tablet	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-046	Oxycodone And Acetaminophen	Oxycodone And Acetaminophen	Tablet	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-058	Acetaminophen And Codeine Phosphate	Acetaminophen And Codeine Phosphate	Tablet	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-059	Acetaminophen And Codeine Phosphate	Acetaminophen And Codeine Phosphate	Tablet	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-060	Acetaminophen And Codeine Phosphate	Acetaminophen And Codeine Phosphate	Tablet	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-105	Phentermine	Phentermine Hydrochloride	Capsule	Oral	Aurolife Pharma, Llc	Human Prescription Drug
13107-106	Phentermine	Phentermine Hydrochloride	Capsule	Oral	Aurolife Pharma, Llc	Human Prescription Drug
65862-050		Simvastatin	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-050	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-051		Simvastatin	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-051	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-052		Simvastatin	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-052	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-053		Simvastatin	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-053	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-054		Simvastatin	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-054	Simvastatin	Simvastatin	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-198		Gabapentin	Capsule		Aurobindo Pharma Limited	Drug For Further Processing
65862-198	Gabapentin	Gabapentin	Capsule	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-199		Gabapentin	Capsule		Aurobindo Pharma Limited	Drug For Further Processing
65862-199	Gabapentin	Gabapentin	Capsule	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-200		Gabapentin	Capsule		Aurobindo Pharma Limited	Drug For Further Processing
65862-200	Gabapentin	Gabapentin	Capsule	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-245		Levetiracetam	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-245	Levetiracetam	Levetiracetam	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-246		Levetiracetam	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-246	Levetiracetam	Levetiracetam	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-247		Levetiracetam	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-247	Levetiracetam	Levetiracetam	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug
65862-315		Levetiracetam	Tablet, Film Coated		Aurobindo Pharma Limited	Drug For Further Processing
65862-315	Levetiracetam	Levetiracetam	Tablet, Film Coated	Oral	Aurobindo Pharma Limited	Human Prescription Drug

Field Name	Field Value
Event ID	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1236-2020 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	Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	2101 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 105180004A, Exp. Date 03/2020 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	13107-105-30; 13107-105-01; 13107-106-30; 13107-106-01
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1231-2020 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	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	57337 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021 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	13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1232-2020 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	Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	26625 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021 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	65862-198-01; 65862-198-05; 65862-198-99; 65862-198-10; 65862-198-90; 65862-198-18; 65862-198-27; 65862-199-01; 65862-199-05; 65862-199-99; 65862-199-10; 65862-199-30; 65862-199-60; 65862-199-90; 65862-199-18; 65862-199-27; 65862-200-01; 65862-200-05; 65862-200-10; 65862-200-90; 65862-200-27
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1237-2020 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	Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	14707 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 046180056A, Exp. Date 05/2020 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	13107-043-30; 13107-043-01; 13107-043-05; 13107-043-99; 13107-044-30; 13107-044-01; 13107-044-05; 13107-044-99; 13107-045-30; 13107-045-01; 13107-045-05; 13107-045-99; 13107-046-30; 13107-046-01; 13107-046-05; 13107-046-99
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1230-2020 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	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	4332 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 059180023A, 059180024A and 059180025A, Exp. Date 05/2021 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	13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1235-2020 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	Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	56208 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 031180028A, Exp. Date 03/2021 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	13107-001-30; 13107-001-60; 13107-001-90; 13107-001-01; 13107-001-05; 13107-031-30; 13107-031-34; 13107-031-60; 13107-031-90; 13107-031-01; 13107-031-05; 13107-031-32; 13107-003-30; 13107-003-34; 13107-003-60; 13107-003-90; 13107-003-01; 13107-003-05; 13107-003-32; 13107-032-34; 13107-032-60; 13107-032-90; 13107-032-01; 13107-032-05; 13107-032-32
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1234-2020 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	Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	26976 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 05319004A1, Exp. Date 03/2022 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	65862-050-30; 65862-050-45; 65862-050-90; 65862-050-01; 65862-050-00; 65862-050-99; 65862-050-26; 65862-051-30; 65862-051-45; 65862-051-90; 65862-051-01; 65862-051-00; 65862-051-99; 65862-051-26; 65862-052-30; 65862-052-45; 65862-052-90; 65862-052-01; 65862-052-00; 65862-052-99; 65862-052-26; 65862-053-30; 65862-053-45; 65862-053-90; 65862-053-01; 65862-053-00; 65862-053-99; 65862-053-22; 65862-054-30; 65862-054-45; 65862-054-90; 65862-054-00; 65862-054-99; 65862-054-39
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1233-2020 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	Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	8040 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 24719001A1, Exp. Date 03/2021 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	65862-245-08; 65862-245-05; 65862-246-08; 65862-246-05; 65862-247-08; 65862-247-05; 65862-315-30; 65862-315-60; 65862-315-05
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	85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1229-2020 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	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
Reason For Recall	CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	14194 units 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	04-22-2020
Recall Initiation Date	03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-25-2024 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	Aurobindo Pharma USA Inc.
Code Info	Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021 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	13107-058-30; 13107-058-01; 13107-058-05; 13107-058-99; 13107-059-30; 13107-059-01; 13107-059-05; 13107-059-99; 13107-060-30; 13107-060-01; 13107-060-05; 13107-060-99
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.