Recall Enforment Report D-0973-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Strides Pharma Inc., originally initiated on 05-18-2022 for the product Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08 The product was recalled due to cgmp deviations- azido impurity levels observed to be above acceptable limits. 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-0973-2022	05-18-2022	06-08-2022	Class II	381456 bottles	Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Terminated
D-0972-2022	05-18-2022	06-08-2022	Class II	200407 bottles	Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Terminated
D-0974-2022	05-18-2022	06-08-2022	Class II	96966 bottles	Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
64380-933	Losartan Potassium 25 mg	Losartan Potassium	Tablet, Film Coated	Oral	Strides Pharma Science Limited	Human Prescription Drug
64380-934	Losartan Potassium 50 mg	Losartan Potassium	Tablet, Film Coated	Oral	Strides Pharma Science Limited	Human Prescription Drug
64380-935	Losartan Potassium 100 mg	Losartan Potassium	Tablet, Film Coated	Oral	Strides Pharma Science Limited	Human Prescription Drug

Field Name	Field Value
Event ID	90229 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0973-2022 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 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	Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-08
Reason For Recall	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	381456 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	06-08-2022
Recall Initiation Date	05-18-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-20-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	N/A 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	Strides Pharma Inc.
Code Info	NDC 64380-934-05 Lot 7901146A, 7901147A, 7901148A & 7901149A, Exp Date Sep-22; Lot 7901279A, 7901280A, 7901281A, 7901282A, 7901283A & 7901284A, Exp Date Nov-22; Lot 7901359A, 7901360A & 7901361A, Exp Date Dec-22; Lot 7901362A, 7901406A, 7901407A, 7901408A & 7901409A, Exp Date Jan-23. 64380-934-08 Lot 7901008A & 7901009A, Exp Date Jun-22; Lot 7901150A & 7901151A, Exp Date Sep-22; Lot 7901285B, 7901286B, 7901287A, 7901288A, 7901289A, 7901290A, 7901291A, 7901292A, 7901293A & 7901294A, Exp Date Nov-22. 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	64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08
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	90229 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0972-2022 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 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	Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08
Reason For Recall	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	200407 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	06-08-2022
Recall Initiation Date	05-18-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-20-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	N/A 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	Strides Pharma Inc.
Code Info	NDC 64380-933-05 Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC 64380-933-08 Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22. 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	64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08
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	90229 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0974-2022 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 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	Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-08
Reason For Recall	CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	96966 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	06-08-2022
Recall Initiation Date	05-18-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-20-2023 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	N/A 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	Strides Pharma Inc.
Code Info	64380-935-05 Lots 7901047B, 7901048B, 7901049B & 7901050B, Exp Date Jul-22; Lots 7901185A, 7901186A, 7901187A & 7901188A, Exp Date Oct-22; Lots 7901250A, 7901251A & 7901252A, Exp Date Nov-22. 64380-935-08 Lots 7900813B, 7900814B, 7900908A, 7900935A, 7900936A, 7900937A, 7900938A & 7900939B, Exp Date May-22; Lots 7901043A, 7901044A, 7901045A & 7901046A, Exp Date Jul-22; Lots 7901158B, 7901159B, 7901160B, 7901161A, 7901182A & 7901183A, Exp Date Sep-22; Lots 7901184A, 7901189A, 7901190A, 7901191A, 7901192A, 7901193A, 7901194A & 7901195A, Exp Date Oct-22; Lots 7901295B, 7901296B, 7901297B, 7901298B, 7901299B, 7901300B, 7901301B & 7901302B, Exp Date Nov-22; Lots 7901338A, 7901339A, 7901340A, 7901341A & 7901342A, Exp Date Dec-22; Lot 7901387A, Exp Date Jan-23 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	64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08
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.