FDAClass IIJanuary 1, 2014

Tacrolimus Capsules recall: Contamination

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC…

Why was Tacrolimus Capsules recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Sandoz Incorporated
Quantity
12,521 bottles
Distribution
Nationwide
Recall date
January 1, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls