Drug product
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
D-1352-2015
Product summary
- Event
- Event 71860
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4776 bottles
- Official record key
drug-enforcement:D-1352-2015
Official wording
Reason: Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Code information: Lot #: GHYL15028, Exp April 2018
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablet