Recalls / Class III
Class IIID-0108-2021
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
- Brand name
- Felodipine
- Generic name
- Felodipine
- Active ingredient
- Felodipine
- Route
- Oral
- NDCs
- 23155-048, 23155-049, 23155-050
- FDA application
- ANDA201964
- Affected lot / code info
- Lot #: 18029979, Exp 1/2021
Why it was 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
Recalling firm
- Firm
- Heritage Pharmaceuticals Inc
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 7176 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2020-10-23
- FDA classified
- 2020-11-25
- Posted by FDA
- 2020-12-02
- Terminated
- 2022-01-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0108-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.