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- FDA Recall: Zenatane
FDA Recall Zenatane
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Zenatane with NDC 55111-113 was initiated on 05-22-2017 as a Class II recall due to failed dissolution specifications: out of specification results observed for low dissolution. The latest recall number for this product is D-0883-2017 and the recall is currently terminated as of 11-19-2018 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0883-2017 | 05-22-2017 | 06-14-2017 | Class II | 13,221 cartons | Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81 | Terminated |
| D-0885-2017 | 05-22-2017 | 06-14-2017 | Class II | 223,650 cartons | Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81 | Terminated |
| D-0886-2017 | 05-22-2017 | 06-14-2017 | Class II | 452,290 cartons | Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81 | Terminated |
| D-0884-2017 | 05-22-2017 | 06-14-2017 | Class II | 89,118 cartons | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81 | Terminated |
| D-0507-2017 | 02-15-2017 | 03-08-2017 | Class III | 12132 cartons | Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81 | Terminated |
| D-0509-2017 | 02-15-2017 | 03-08-2017 | Class III | 4404 cartons | Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81 | Terminated |
| D-0506-2017 | 02-15-2017 | 03-08-2017 | Class III | 4032 cartons | Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81 | Terminated |
| D-0098-2017 | 08-29-2016 | 10-19-2016 | Class III | 3,858 prescription packs (115,680 capsules) | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81 | 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-0883-2017
- Event ID
- 77353 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0883-2017 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 and Puerto Rico 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
- Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
- Reason For Recall
- Failed Dissolution Specifications: out of specification results observed for low dissolution. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 13,221 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-14-2017
- Recall Initiation Date
- 05-22-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-19-2018 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot #: KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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-0885-2017
- Event ID
- 77353 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0885-2017 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 and Puerto Rico 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
- Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-113-81
- Reason For Recall
- Failed Dissolution Specifications: out of specification results observed for low dissolution. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 223,650 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-14-2017
- Recall Initiation Date
- 05-22-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-19-2018 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot #: KB50414, KB50456, Exp 05/17; KB50457, KB50458, KB50459, KB50460, Exp 06/17; KB50580, KB50581, KB50582, KB50583, KB50599, KB50600, Exp 07/17; KB50646, KB50647, KB50721, KB50722, KB50723, KB50724, Exp 09/17; KB50833, KB50834, KB50835, KB50836, KB50837, Exp 10/17; KB50902, KB50903, KB50904, Exp 11/17; KB60037, KB60038, KB60039, KB60040, KB60041, Exp 12/17; KB60109, KB60110, KB60111, KB60112, KB60113, Exp 01/18; 01KB60249, 01KB60266, 01KB60268, 01KB60269, 01KB60284, Exp 03/18; 01KB60369, 01KB60372, 79KB60368, 79KB60371, Exp 05/18; 79KB60507, 79KB60508, 79KB60509, 79KB60510, 79KB60511, 79KB60512, 79KB60513, 79KB60514, 79KB60515, 79KB60516, Exp 07/18; 79KB60570, 79KB60571, 79KB60585, 79KB60586, Exp 08/18; 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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-0886-2017
- Event ID
- 77353 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0886-2017 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 and Puerto Rico 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
- Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-137-81
- Reason For Recall
- Failed Dissolution Specifications: out of specification results observed for low dissolution. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 452,290 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-14-2017
- Recall Initiation Date
- 05-22-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-19-2018 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot #: KB50363, KB50364, KB50365, KB50366, KB50367, KB50368, KB50369, KB50370, KB50371, Exp 05/17; 01KB50598, KB50541, KB50542, KB50543, KB50544, KB50545, KB50546, KB50547, KB50548, KB50549, KB50550, KB50551, Exp 07/17; 01KB50643, 01KB50644, KB50640, KB50641, KB50642, KB50645, Exp 08/17; KB50715, KB50716, KB50717, KB50718, KB50719, KB50720, KB50757, KB50758, KB50759, KB50760, KB50761, Exp 09/17; KB50872, KB50874, KB50875, KB50876, KB50916, KB50938, KB50943, Exp 11/17; 01KB60062, 01KB60063, 01KB60064, 01KB60065, 01KB60066, 01KB60101, KB60025, KB60026, KB60027, KB60028, KB60029, KB60030, KB60031, KB60032, KB60059, KB60060, KB60061, Exp 12/17; 01KB60100, 01KB60161, Exp 01/18; 01KB60256, 01KB60257, 01KB60258, 01KB60259, 01KB60260, Exp 03/18; 01KB60292, 01KB60293, 01KB60294, 01KB60314, 01KB60321, 01KB60333, 01KB60334, 79KB60295, 79KB60296, 79KB60332, 79KB60335, 79KB60346, Exp 04/18; 01KB60393, 01KB60394, 79KB60390, 79KB60391, 79KB60392, Exp 05/18; 01KB60505, 01KB60506, 01KB60538, 79KB60502, 79KB60503, 79KB60504, 79KB60535, 79KB60536, 79KB60537, 79KB60539, 79KB60542, Exp 07/18; 01KB60589, 79KB60566, 79KB60567, 79KB60568, 79KB60569, 79KB60587, 79KB60588, Exp 08/18 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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-0884-2017
- Event ID
- 77353 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0884-2017 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 and Puerto Rico 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
- Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
- Reason For Recall
- Failed Dissolution Specifications: out of specification results observed for low dissolution. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 89,118 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-14-2017
- Recall Initiation Date
- 05-22-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-19-2018 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot #: KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79KB60420, Exp 06/18 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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-0507-2017
- Event ID
- 76539 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0507-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
- Reason For Recall
- Failed dissolution specifications - low dissolution results at S3 stage. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 12132 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 03-08-2017
- Recall Initiation Date
- 02-15-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 12-19-2018 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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-0509-2017
- Event ID
- 76539 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0509-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
- Reason For Recall
- Failed dissolution specifications - low dissolution results at S3 stage. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4404 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 03-08-2017
- Recall Initiation Date
- 02-15-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 12-19-2018 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot # KB60197, Exp 2/18 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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-0506-2017
- Event ID
- 76539 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0506-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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
- U.S. Nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81
- Reason For Recall
- Failed dissolution specifications - low dissolution results at S3 stage. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 4032 cartons Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 03-08-2017
- Recall Initiation Date
- 02-15-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 12-19-2018 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot # 01KB60250, Exp 3/18 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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-0098-2017
- Event ID
- 75162 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0098-2017 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- nationwide What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - Product Description
- ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
- Reason For Recall
- Failed Dissolution Specifications What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 3,858 prescription packs (115,680 capsules) 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
- 10-19-2016
- Recall Initiation Date
- 08-29-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 11-08-2019 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
- Dr. Reddy's Laboratories, Inc.
- Code Info
- Lot # 79KB60205; Exp. 02/18 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
- 55111-135-79; 55111-135-81; 55111-136-79; 55111-136-81; 55111-137-79; 55111-137-81; 55111-113-79; 55111-113-81; 55111-113-78
- 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.