Why it was recalled
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
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
Lot numbers, UPCs & expiration codes
Lot#: 7901903A, exp. date 04/2024
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0895-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2023
- FDA report date
- Jul 12, 2023
- Quantity
- 2,700 HDPE Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0895-2023, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92584
- Address
- 2 Tower Center Blvd Ste 1102
- Code information
- Lot#: 7901903A, exp. date 04/2024
- Postal code
- 08816-1100
- Report date
- Jul 12, 2023
- Product type
- Drugs
- Recall number
- D-0895-2023
- Classification
- Class II
- Recalling firm
- Strides Pharma Inc.
- Product quantity
- 2,700 HDPE Bottles
- Termination date
- May 15, 2024
- Reason for recall
- Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Jun 26, 2023
- Initial firm notification
- Letter
- Center classification date
- Jul 6, 2023