Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritag...
FDA Recall #D-0108-2021 — Class III — October 23, 2020
Product Description
Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
Reason for Recall
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Recalling Firm
Heritage Pharmaceuticals Inc — East Brunswick, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
7176 bottles
Distribution
USA Nationwide
Code Information
Lot #: 18029979, Exp 1/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated