Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuti...
FDA Recall #D-0223-2018 — Class III — December 22, 2017
Product Description
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
Reason for Recall
Presence of foreign substance: metallic razor blade was found in one bottle.
Recalling Firm
Hetero Labs, Ltd. - Unit III — Hyderabad, N/A
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
N/A
Distribution
U.S.A. nationwide
Code Information
Lot #: E171280, Exp 06/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated