June 2017 FDA Recall Amitriptyline Hydrochloride by Sandoz Incorporated
D-0943-2017 - Cross Contamination With Other Product
This Class III drug recall was voluntarily initiated by Sandoz Incorporated on June 16, 2017 for the product Amitriptyline Hydrochloride. The FDA reported the reason for recall as cross contamination with other product. The product was distributed in Product was distributed throughout the United States and the recall is currently terminated.
Recall Number: D-0943-2017
Cross Contamination With Other Product: Imipramine
06-16-2017
07-12-2017
38,234 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.
Sandoz Incorporated
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.
Product was distributed throughout the United States
01-14-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540
Batch or Lot Expiration Information
Lot# : a) GR3831, GS9690, Exp. 08/2019; b) GR3832, Exp. 08/2019.
