October 2020 FDA Recall Felodipine by Heritage Pharmaceuticals Inc
D-0108-2021 - Failed impurities/ degradation specifications
This Class III drug recall was voluntarily initiated by Heritage Pharmaceuticals Inc on October 23, 2020 for the product Felodipine. The FDA reported the reason for recall as failed impurities/ degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0108-2021
Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
10-23-2020
12-02-2020
7176 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Heritage Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
01-28-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 18029979, Exp 1/2021
