March 2017 FDA Recall Rivastigmine Tartrate by Dr. Reddy's Laboratories, Inc.
D-0649-2017 - Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on March 6, 2017 for the product Rivastigmine Tartrate. The FDA reported the reason for recall as cross-contamination with other products -related substances test for rivastigmine tartrate capsules usp, 1.5 mg showed a peak for ranitidine.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0649-2017
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
03-06-2017
04-12-2017
1,728 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.
Dr. Reddy's Laboratories, 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.
U.S. nationwide
12-21-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60
Batch or Lot Expiration Information
Lot# C607323, Exp 10/18
