Class II · Moderate risk Ongoing
Guardian Bismuth Chwble Chry Tabs 30 Ctsku 902321 Ric Bismuth…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Bismuth Subsalicylate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 00093746556, Pedigree: AD42592_7, EXP: 5/14/2014.
What was recalled
BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00603023516.
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-981-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Bismuth recalls
See all
Class II · Moderate risk Terminated
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk Terminated
Bismuth Subcarbonate active pharmaceutical ingredient packaged in…
Reason 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.
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