October 2018 FDA Recall Amlodipine Besylate by Invagen Pharmaceuticals, Inc.
D-0012-2019 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Invagen Pharmaceuticals, Inc. on October 3, 2018 for the product Amlodipine Besylate. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0012-2019
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
10-03-2018
10-17-2018
2880 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.
InvaGen 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.
Nationwide with the United States
07-13-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
Batch or Lot Expiration Information
Lot# : GG80218, Exp. 12/2019
