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Class II: temporary or reversible health riskTerminated

Sandoz Tacrolimus Capsules Recall

Tacrolimus Capsules, USP, 0

Sandoz Incorporated · Broomfield, CO

Risk level
Class II
Reported by FDA
Jan 1, 2014
Recall ID
D-383-2014
Check your lot numberHow we source this data

Summary

Sandoz recalled Tacrolimus Capsules starting Oct 22, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-383-2014 on Jan 1, 2014. Reason: Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-383-2014
Classification
Class II
Status
Terminated
Recall initiated
Oct 22, 2013
FDA report date
Jan 1, 2014
Quantity
12,521 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Sandoz Incorporated

Original FDA data

Every field from FDA enforcement report D-383-2014, exactly as published.

Show all FDA fields
City
Broomfield
State
CO
Status
Terminated
Country
United States
Event ID
66531
Address
2555 W Midway Blvd
Code information
Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Postal code
80020-1632
Report date
Jan 1, 2014
Product type
Drugs
Recall number
D-383-2014
Classification
Class II
Recalling firm
Sandoz Incorporated
Product quantity
12,521 bottles
Termination date
Jul 10, 2014
Reason for recall
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Oct 22, 2013
Initial firm notification
Letter
Center classification date
Dec 20, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-383-2014, published Jan 1, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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