Losartan Potassium Tablet, Film Coated
FDA Recall NDC 64380-933

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 4 recorded enforcement report(s) associated with Losartan Potassium (NDC 64380-933). A significant event, classified as Class II, was initiated on Jun 26, 2023 by Strides Pharma Science Limited. The reported reason for this action was: "Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet."

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0895-2023TERMINATEDD-0973-2022TERMINATEDD-0972-2022TERMINATEDD-0974-2022TERMINATED

June 2023 Class II Recall: Presence of Foreign Substance

Recall Number
D-0895-2023
Class II Terminated
Reason for Recall
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Initiated
Jun 26, 2023
Reported
Jul 12, 2023
Quantity
2,700 HDPE Bottles

Recall Profile & Regulatory Data

Event ID
92584
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
May 15, 2024
Product Description
Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08
Batch or Lot Expiration Information
Lot# : 7901903A, exp. date 04/2024
Affected Packages Involved in this Recall
64380-933-04Product
64380-933-05Product
64380-933-08Product
64380-934-04Product
64380-934-05Product
64380-934-08Product
64380-935-04Product
64380-935-05Product
64380-935-08Product

May 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Recall Number
D-0973-2022
Class II Terminated
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Initiated
May 18, 2022
Reported
Jun 08, 2022
Quantity
381456 bottles

Recall Profile & Regulatory Data

Event ID
90229
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 20, 2023
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
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
64380-933-04Product
64380-933-05Product
64380-933-08Product
64380-934-04Product
64380-934-05Product
64380-934-08Product
64380-935-04Product
64380-935-05Product
64380-935-08Product

May 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Recall Number
D-0972-2022
Class II Terminated
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Initiated
May 18, 2022
Reported
Jun 08, 2022
Quantity
200407 bottles

Recall Profile & Regulatory Data

Event ID
90229
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 20, 2023
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
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
64380-933-04Product
64380-933-05Product
64380-933-08Product
64380-934-04Product
64380-934-05Product
64380-934-08Product
64380-935-04Product
64380-935-05Product
64380-935-08Product

May 2022 Class II Recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Recall Number
D-0974-2022
Class II Terminated
Reason for Recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Initiated
May 18, 2022
Reported
Jun 08, 2022
Quantity
96966 bottles

Recall Profile & Regulatory Data

Event ID
90229
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Oct 20, 2023
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
64380-933-04Product
64380-933-05Product
64380-933-08Product
64380-934-04Product
64380-934-05Product
64380-934-08Product
64380-935-04Product
64380-935-05Product
64380-935-08Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.