Status
Terminated
Drug Enforcement D-0895-2023
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Classification
Class II
Report Date
July 12, 2023
Termination Date
May 15, 2024
Product Information
- 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
- Product quantity
- 2,700 HDPE Bottles
- Reason for recall
- Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Strides Pharma Inc.
- Address
-
2 Tower Center Blvd Ste 1102, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0895-2023
- Event ID
- 92584
- Recall initiation date
- June 26, 2023
- Center classification date
- July 6, 2023
- Code info
- Lot#: 7901903A, exp. date 04/2024
- More code info
- —