Felodipine Extended Release Tablets recall: Impurity Out of Spec
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
Why was Felodipine Extended Release Tablets recalled?
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 18029979, Exp 1/2021
- 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
- Recalling firm
- Heritage Pharmaceuticals Inc
- Quantity
- 7176 bottles
- Distribution
- USA Nationwide
- Recall date
- December 2, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)