Drug 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
D-0895-2023
Product summary
- Event
- Event 92584
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,700 HDPE Bottles
- Official record key
drug-enforcement:D-0895-2023
Official wording
Reason: Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Code information: Lot#: 7901903A, exp. date 04/2024
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance