Fosinopril Sodium Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling 10 mg Fosinopril Sodium tablets that may be mislabeled as Calcitriol capsules due to a labeling mixup.
What this means for you
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 mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.
Plain-English summary
Aidapak Services, LLC is recalling 90-count bottles of Fosinopril Sodium Tablet, 10 mg, NDC 60505251002. The recall is due to a labeling mixup where the product may be potentially mislabeled as Calcitriol, Capsule, 0.25 mcg, NDC 00054000725. The affected lot has the pedigree AD46414_19 and an expiration date of 5/16/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- FOSINOPRIL SODIUM Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505251002
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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)
- FOSINOPRIL SODIUM
- Tablet
- 10 mg has the following code Pedigree: AD46414_19
- EXP: 5/16/2014.
Distribution
Part of a larger recall action
This product is one of 273 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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