Drug recall D-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
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
Lots and codes
Lot #: 18029979, Exp 1/2021
Recall details
- Recalling firm
- Heritage Pharmaceuticals Inc, East Brunswick, NJ
- Quantity
- 7176 bottles
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 23, 2020
- Terminated
- January 28, 2022
Related products
- Felodipine – drug information
- NDC 23155-050 Felodipine · Felodipine 10 mg/1 · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC 23155-048 Felodipine · Felodipine 2.5 mg/1 · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC 23155-049 Felodipine · Felodipine 5 mg/1 · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.