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- FDA Recall: Pramipexole Dihydrochloride
FDA Recall Pramipexole Dihydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Pramipexole Dihydrochloride with NDC 68382-197 was initiated on 05-06-2019 as a Class II recall due to cgmp deviations: cross contamination with other products due to cgmp cleaning failure. The latest recall number for this product is D-1444-2019 and the recall is currently terminated as of 09-16-2021 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
Recall Enforcement Report D-1444-2019
- 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.
Recall Enforcement Report D-1443-2019
- 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.
Recall Enforcement Report D-1452-2019
- 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.
Recall Enforcement Report D-1445-2019
- 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.
Recall Enforcement Report D-1446-2019
- 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.
Recall Enforcement Report D-1442-2019
- 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.
Recall Enforcement Report D-1447-2019
- 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.