Hetero Labs, Ltd. - Unit III recalls Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway…

Recall date

December 22, 2017

Source

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

Recall number

D-0223-2018

FDA classification

Class III

Brand / firm

Hetero Labs, Ltd. - Unit III

Sold / distributed

U.S.A. nationwide

Why it was recalled

Presence of foreign substance: metallic razor blade was found in one bottle.

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

What was recalled

Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10