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Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz P...

FDA Recall #D-383-2014 — Class II — October 22, 2013

Recall #D-383-2014 Date: October 22, 2013 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

Recalling Firm

Sandoz Incorporated — Broomfield, CO

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

12,521 bottles

Distribution

Nationwide

Code Information

Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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