Hetero Labs, Ltd. - Unit III recalls Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway,…

Recall date

September 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1211-2018

FDA classification

Class III

Brand / firm

Hetero Labs, Ltd. - Unit III

Sold / distributed

Indiana and Louisiana

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90