FDA Recalls Bismuth Subsalicylate Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Bismuth Subsalicylate chewable tablets that may have been mislabeled as Irbesartan. The error could lead to patients taking the wrong medication.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential medication errors that could lead to adverse health consequences.
Plain-English summary
Aidapak Services, LLC is recalling Bismuth Subsalicylate, Chew Tablet, 262 mg (NDC 00603023516) due to a labeling error. The product may have been mislabeled as Irbesartan, Tablet, 150 mg (NDC 00093746556). The affected lot has pedigree AD42592_10 and an expiration date of 5/14/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers should check their medication labels and discontinue use if the product matches the description above. Patients should consult their healthcare provider or pharmacist for guidance on appropriate treatment.
The recalled product
- Product
- BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00603023516.
- Manufacturer
- Aidapak Services, LLC
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- BISMUTH SUBSALICYLATE
- CHEW Tablet
- 262 mg has the following codes: Pedigree: AD42592_10
- EXP: 5/14/2014.
Distribution
Part of a larger recall action
This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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