Class III
Terminated
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
- Company
- Heritage Pharmaceuticals Inc
- Recall Initiated
- October 23, 2020
- Posted
- December 2, 2020
- Recall Number
- D-0108-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7176 bottles
- Firm Location
- East Brunswick, NJ, United States
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
Distribution
USA Nationwide
Lot / Code Info
Lot #: 18029979, Exp 1/2021
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