Sandoz recalls 0.5 mg Tacrolimus Capsules due to trace fluvastatin contamination from previous batch. Affected lots: DE9898-DE9911, expiring June 2014. No immediate action needed but check your bottle.
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Sandoz is recalling 0.5 mg Tacrolimus capsules that may contain trace amounts of fluvastatin from a previous batch. This cross-contamination could affect patients taking immunosuppressants, though the risk is low and no immediate action is required.
Trace amounts of fluvastatin, a different drug, may have been carried over from a previous batch during manufacturing. This cross-contamination could potentially interact with the patient's medication, though the amounts are minimal.
Patients prescribed Tacrolimus capsules for immunosuppression are most at risk. The recall applies to specific lots manufactured in India for Sandoz Inc. in 2014.
Check for the lot numbers DE9898, DE9900, DE9903, DE9908, or DE9911 on the bottle. The product expires June 2014 and contains 100 capsules of 0.5 mg Tacrolimus.
Look for the lot numbers DE9898, DE9900, DE9903, DE9908, or DE9911 on the bottle label.
No immediate action is required. The recall is for specific lots that may have trace contamination, but patients can continue using their current supply.
Check your bottle for the lot numbers DE9898-DE9911. If you have these, contact Sandoz for guidance.
The risk is low as only trace amounts of fluvastatin may be present, and no serious injury has been reported.
We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.
Subject: Recall D-383-2014 — Sandoz Sandoz Hello, I own a Sandoz that is covered by recall D-383-2014 from Sandoz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
