Drug product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90-tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC # 59746-339-90
D-1500-2014
Product summary
- Event
- Event 68776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,358 bottles
- Official record key
drug-enforcement:D-1500-2014
Official wording
Reason: Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.
Code information: Lot #14P0292, Exp 04/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance