FDA Recalls Calcium Polycarbophil Tablets Due to Labeling Error
Aidapak Services, LLC is recalling Calcium Polycarbophil tablets that may be mislabeled as Caffeine tablets. The error involves a label mixup during repacking.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Calcium Polycarbophil, Tablet, 625 mg, Over The Counter, distributed by AidaPak Service, LLC (NDC 00536430611). The recall is due to a labeling error where the product may have been mislabeled as CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173.
The affected product is identified by Pedigree AD73592_11 and an expiration date of 5/31/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree codes listed above. If the product matches the description, they should stop using it and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- CALCIUM POLYCARBOPHIL, Tablet, 625 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536430611.
- Manufacturer
- Aidapak Services, LLC
- Hazard
- Affected units
- 90
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)
- CALCIUM POLYCARBOPHIL
- Tablet
- 625 mg has the following codes: Pedigree: AD73592_11
- EXP: 5/31/2014.
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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