October 2014 FDA Recall Amlodipine Besylate by Zydus Pharmaceuticals Usa Inc
D-0257-2015 - Discoloration
This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on October 1, 2014 for the product Amlodipine Besylate. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0257-2015
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
10-01-2014
12-03-2014
15,144 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.
Zydus Pharmaceuticals USA 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
02-26-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-123-16
Batch or Lot Expiration Information
Lot# : MP4344, Exp 04/2016
