Carvedilol Phosphate ER Capsules Recalled for Potential Labeling Error
Aidapak Services is recalling Carvedilol Phosphate ER capsules due to a potential label mixup with Bumetanide tablets.
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 Carvedilol Phosphate ER, Capsule, 20 mg (NDC 00007337113) due to a labeling error. The recall is initiated because the product may be potentially mislabeled as Bumetanide, Tablet, 1 mg (NDC 00093423301). Both products share the same pedigree number (W003224) and expiration date (6/17/2014), increasing the risk of dispensing errors.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific lot size is 29 capsules. This is a Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Carvedilol Phosphate ER capsules with the specified NDC and pedigree. If found, they should stop using the product and contact the recalling firm or their pharmacist for instructions on return or replacement.
The recalled product
- Product
- CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00007337113.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 29
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)
- CARVEDILOL PHOSPHATE ER
- Capsule
- 20 mg has the following codes: Pedigree: W003225
- EXP: 6/17/2014.
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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