FDA-Drug2020-12-02Class III

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

Heritage Pharmaceuticals Inc
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

Sold states
USA Nationwide
Affected count
7176 bottles
Manufactured in
1 Tower Center Blvd Ste 1700, N/A, East Brunswick, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0108-2021

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