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Class II · ModerateRecall completed

Pantoprazole Sodium Monohydrate active pharmaceutical ingredient packaged in var

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberAll lots repackaged and distributed between 01/05/12 to 02/12/15
Where it was soldNationwide to compounding pharmacies and research organizations.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forAttix Pharmaceuticals
Show the full FDA record
Full product labelPantoprazole Sodium Monohydrate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Recalling firmAttix Pharmaceuticals
DistributionNationwide to compounding pharmacies and research organizations.
Quantity1800 grams
Recall initiated2014-11-14
Report date2015-04-29
Recall completed2015-10-07
Recall numberD-831-2015
ClassificationClass II
FDA statusTerminated
Origin on fileToronto Canada

Related

Pantoprazole recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.