Recall Enforment Report D-1441-2019

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Zydus Pharmaceuticals USA Inc, originally initiated on 05-06-2019 for the product Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10 The product was recalled due to cgmp deviations: cross contamination with other products due to cgmp cleaning failure.. 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-1441-2019	05-06-2019	06-26-2019	Class II	768 1000-count bottles	Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1453-2019	05-06-2019	06-26-2019	Class II	40872 25-count bottles	MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1440-2019	05-06-2019	06-26-2019	Class II	1,425,264 30-count bottles	ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1451-2019	05-06-2019	06-26-2019	Class II	13,564 25-count bottles	MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1448-2019	05-06-2019	06-26-2019	Class II	34521 100-count bottles	MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1447-2019	05-06-2019	06-26-2019	Class II	113,304 90-count bottles	Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1446-2019	05-06-2019	06-26-2019	Class II	168,330 90-count bottles	Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1450-2019	05-06-2019	06-26-2019	Class II	N/A	MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1449-2019	05-06-2019	06-26-2019	Class II	N/A	MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1444-2019	05-06-2019	06-26-2019	Class II	215,760 90-count bottles	Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1443-2019	05-06-2019	06-26-2019	Class II	143,184 90-count bottles	Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1452-2019	05-06-2019	06-26-2019	Class II	47,664 90-count bottles	Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1445-2019	05-06-2019	06-26-2019	Class II	3,156 1000-count bottles	Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated
D-1442-2019	05-06-2019	06-26-2019	Class II	204 1000-count bottles	Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
68382-196	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-197	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-198	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-199	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-200	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-209	Anastrozole	Anastrozole	Tablet, Coated	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-440	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-916	Methylprednisolone	Methylprednisolone	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-917	Methylprednisolone	Methylprednisolone	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-918	Methylprednisolone	Methylprednisolone	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug
68382-919	Methylprednisolone	Methylprednisolone	Tablet	Oral	Zydus Pharmaceuticals Usa Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1441-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	768 1000-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20 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	68382-209-06; 68382-209-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1453-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	40872 25-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M713224, M713225, M713226, EXP Nov-19; M814746 EXP Sep-20; M816148 EXP Oct-20; M901600, M901601 EXP Feb-21 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	68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1440-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	1,425,264 30-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lot: M706674, M706676, M707685 EXP Jun-19; M711219, M711220, M711221, M711222, M711269, EXP Sep-19; M801027, EXP Dec-19; M801028, M801029, M801030, EXP Jan-20; M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20; M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957, M805958, M805959 Apr-20; M812457, EXP Jul-20, M812458, M812459, M813912, M813913, M813914, M813915, M813916, EXP Aug-20; M815768, M815769, M818274, EXP Oct-20; M818119, M818120, M818121, M818635, EXP Nov-20; M819270, M819861, M819862, EXP Dec-20; M900921, M900922, M900923, M900924, M900925, EXP Jan-21; M902634, M902635, EXP Feb-21. 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	68382-209-06; 68382-209-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1451-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	13,564 25-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M713043, M713047, EXP Dec-19; M713045, EXP Nov- 19; M816143, EXP Oct-20. 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	68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1448-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	34521 100-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M800144, M800145, EXP, Feb-20; M808193, EXP Jun-20; M811096, EXPJul-20 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	68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1447-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	113,304 90-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M714186 M714187 M714188 EXP Oct-19; M714903 M714904 M714905 M715586 M715587 EXP Nov-19; M801441 M801442 M801443 M801444 M801445 EXP Dec-19; M811152 M811153 M811154 M811155 M811156 M814298 EXP Jul-20; M814299 M814300 M814301 M814302 EXP Aug-20; M818136 M818137 M818138 M818139 M818140 EXP Nov-20 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	68382-196-16; 68382-196-05; 68382-196-10; 68382-197-16; 68382-197-05; 68382-197-10; 68382-198-16; 68382-198-05; 68382-198-10; 68382-199-16; 68382-199-05; 68382-199-10; 68382-200-16; 68382-200-05; 68382-200-10; 68382-440-16; 68382-440-05; 68382-440-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1446-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	168,330 90-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots:M713431, M713432, M714172, EXP Sep-19; M714173, Oct-19; M800552, M800553, M800554, M800555 M800556 EXP Dec-19; M811135 M812818 M812819 M812820 M812821 EXP Jun-20, M815777 M815778 M815779 M815780 M815781 EXP Aug-20; M901927 M901929 M901931 M901933 M902089 EXP Jan-21 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	68382-196-16; 68382-196-05; 68382-196-10; 68382-197-16; 68382-197-05; 68382-197-10; 68382-198-16; 68382-198-05; 68382-198-10; 68382-199-16; 68382-199-05; 68382-199-10; 68382-200-16; 68382-200-05; 68382-200-10; 68382-440-16; 68382-440-05; 68382-440-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1450-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	lots: M713034, M713035, M713036, EXP Nov-19; M814747 Sep-20; M819266, EXP Dec-20 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	68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1449-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	N/A Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M800150 Feb-20; M803930, M806006, M806007, M806008, M806009, M806010, M806011, EXP Mar-20; M807299, M807300, M807301, M807302, M807303, M807304, M807305, M807306, M807307, M807308, EXP May-20; M807779, M807780, M808194, M808195, M808196, M808197, M808198, EXP Jun-20; M811092, M811093, M811094, M811097, M811665, M811666, M811667, M813781, EXP Jul-20; M816286, M816288, M816289, M816290, M817612, EXP OCT-20; M817613, M817614, M817615, M817616, M818315, EXP Nov-20; M820619, M820620, M820621, M901594, M901595, M901596, M901597, M903484, EXP Mar-21 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	68382-916-01; 68382-916-05; 68382-916-34; 68382-917-11; 68382-917-01; 68382-917-05; 68382-917-30; 68382-917-77; 68382-918-18; 68382-918-01; 68382-918-05; 68382-918-30; 68382-918-77; 68382-919-11; 68382-919-01; 68382-919-05; 68382-919-30; 68382-919-77
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1444-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	215,760 90-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M706802, M706804, M706907, M706909, M707028, EXP May-19; M714180, M714181, EXP Oct-19; M717063, M717064, M801705, M801706, M801707, M801708, M714923, M714924, M714925 EXP Dec-19; M808307, M808308, M808309, M808310, EXP May-20; M812479, M812481, M812482, M812483, EXP Jul-20; M815787 M815789, M815790, M815791, M815788, EXP Sep-20; M820266, M820267, M820268, M820269, M820265 EXP Nov-20; M903040, M903041, M903042 EXP Jan-21. 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	68382-196-16; 68382-196-05; 68382-196-10; 68382-197-16; 68382-197-05; 68382-197-10; 68382-198-16; 68382-198-05; 68382-198-10; 68382-199-16; 68382-199-05; 68382-199-10; 68382-200-16; 68382-200-05; 68382-200-10; 68382-440-16; 68382-440-05; 68382-440-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1443-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	143,184 90-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lot: M714176, M714177, EXP Oct-19; M714917, EXP Nov-19; M714918, M715594, M715595, EXP Dec-19; M802190, EXP Jan-20; M802191, EXP Feb-20, M808673, EXP May-20; M811125, M811126, M811127, M811128, M811129, EXP Jun-20; M815082, M815083, M815084, M815085, M815086 EXP Aug-20; M900476, M900477, M900478, M900479, M900481, Dec-20; 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	68382-196-16; 68382-196-05; 68382-196-10; 68382-197-16; 68382-197-05; 68382-197-10; 68382-198-16; 68382-198-05; 68382-198-10; 68382-199-16; 68382-199-05; 68382-199-10; 68382-200-16; 68382-200-05; 68382-200-10; 68382-440-16; 68382-440-05; 68382-440-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1452-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	47,664 90-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M713435 M713436 EXP Sep-19; M714191 EXP Oct-19; M808185 M808184 M808186 EXP May-20; M817634 M817635 EXP Nov-20 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	68382-196-16; 68382-196-05; 68382-196-10; 68382-197-16; 68382-197-05; 68382-197-10; 68382-198-16; 68382-198-05; 68382-198-10; 68382-199-16; 68382-199-05; 68382-199-10; 68382-200-16; 68382-200-05; 68382-200-10; 68382-440-16; 68382-440-05; 68382-440-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1445-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	3,156 1000-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lots: M706803, EXP Jun-19; M713438, EXP Oct-19; M801704, EXP Jan-20; M808306, EXP Jun-20; M812484, EXP Aug-20; M820264, EXP Dec-20 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	68382-196-16; 68382-196-05; 68382-196-10; 68382-197-16; 68382-197-05; 68382-197-10; 68382-198-16; 68382-198-05; 68382-198-10; 68382-199-16; 68382-199-05; 68382-199-10; 68382-200-16; 68382-200-05; 68382-200-10; 68382-440-16; 68382-440-05; 68382-440-10
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	82827 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1442-2019 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA 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	Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
Reason For Recall	CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	204 1000-count 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	06-26-2019
Recall Initiation Date	05-06-2019 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	09-16-2021 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Zydus Pharmaceuticals USA Inc
Code Info	Lot: M714919, EXP Dec-19, M815081, EXP Aug-20, M900475, EXP Dec-20 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	68382-196-16; 68382-196-05; 68382-196-10; 68382-197-16; 68382-197-05; 68382-197-10; 68382-198-16; 68382-198-05; 68382-198-10; 68382-199-16; 68382-199-05; 68382-199-10; 68382-200-16; 68382-200-05; 68382-200-10; 68382-440-16; 68382-440-05; 68382-440-10
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.