Fenofibrate Tablets, USP 145 mg, 90-count bottles recall — FDA D-1211-2018
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Overview of recall records associated with Hetero Labs, Ltd. - Unit III, including dates, categories and classifications where available.
Classification mix: Class II: 3, Class III: 2.
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Presence of foreign substance: metallic razor blade was found in one bottle.
Presence of foreign substance (screw)
This page summarizes recall records in which the official source identifies Hetero Labs, Ltd. - Unit III as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.