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
Reported: December 2, 2020 Initiated: October 23, 2020 #D-0108-2021
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
Details
- Recalling Firm
- Heritage Pharmaceuticals Inc
- Units Affected
- 7176 bottles
- Distribution
- USA Nationwide
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Heritage Pharmaceuticals Inc. Units affected: 7176 bottles.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 2, 2020. Severity: Low. Recall number: D-0108-2021.
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