June 2023 FDA Recall Losartan Potassium by Strides Pharma Inc.
D-0895-2023 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Strides Pharma Inc. on June 26, 2023 for the product Losartan Potassium. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0895-2023

Reason for Recall
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Initiated
06-26-2023
Reported
07-12-2023
Quantity
2,700 HDPE Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92584
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Strides Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
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

64380-933-04 Losartan Potassium 25 Mg
64380-933-05 Losartan Potassium 25 Mg
64380-933-08 Losartan Potassium 25 Mg
64380-934-04 Losartan Potassium 50 Mg
64380-934-05 Losartan Potassium 50 Mg
64380-934-08 Losartan Potassium 50 Mg
64380-935-04 Losartan Potassium 100 Mg
64380-935-05 Losartan Potassium 100 Mg
64380-935-08 Losartan Potassium 100 Mg