Recalls / Class II
Class IID-0895-2023
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
- Brand name
- Losartan Potassium
- Generic name
- Losartan Potassium
- Active ingredient
- Losartan Potassium
- Route
- Oral
- NDCs
- 64380-933, 64380-934, 64380-935
- FDA application
- ANDA090382
- Affected lot / code info
- Lot#: 7901903A, exp. date 04/2024
Why it was recalled
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Recalling firm
- Firm
- Strides Pharma Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1102, N/A, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 2,700 HDPE Bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-06-26
- FDA classified
- 2023-07-06
- Posted by FDA
- 2023-07-12
- Terminated
- 2024-05-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0895-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.