Heritage Pharmaceuticals Inc recalls Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.

Recalled December 2, 2020 · FDA recall D-0108-2021 · Heritage Pharmaceuticals

Hazard

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A · FDA Class III

Units

7176 bottles

Sold at

USA Nationwide

Description

Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

Product

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

Manufacturer(s)

Heritage Pharmaceuticals Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →