October 2013 FDA Recall Tacrolimus by Sandoz Incorporated
D-383-2014 - Cross Contamination with Other Products
This Class II drug recall was voluntarily initiated by Sandoz Incorporated on October 22, 2013 for the product Tacrolimus. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-383-2014
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
10-22-2013
01-01-2014
12,521 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Nationwide
07-10-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Batch or Lot Expiration Information
Lot# Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
