FDAFDA · Food and drugs·Recall number D-0108-2021
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
Published December 2, 2020 · Recall initiated: October 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FELODIPINE
- Manufacturer
- Heritage Pharmaceuticals Inc
- Distributor
- USA Nationwide
- UPC
- 0323155049015
- Lot
- Lot #: 18029979, Exp 1/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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