Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceutica...
FDA Recall #D-0453-2017 — Class III — December 29, 2016
Product Description
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Reason for Recall
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
Recalling Firm
Hetero Drugs Ltd. - Unit 1 — Medak District, N/A
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
20,412 units
Distribution
NJ only.
Code Information
Lot #: FIN16002, Exp. 03/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated