Fluvastatin Capsules Recalled for Potential Labeling Mixup
Aidapak Services is recalling Fluvastatin 20 mg capsules because they may have been mislabeled as a different medication.
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, which corresponds to a moderate severity score for labeling errors that may cause temporary or medically reversible health consequences.
Plain-English summary
Aidapak Services, LLC is recalling Fluvastatin, Capsule, 20 mg (NDC 00378802077) due to a potential labeling mixup. The recalled product may have been incorrectly labeled as Acetaminophen/Butalbital/Caffeine, Tablet, 325 mg/50 mg/40 mg (NDC 00603254421).
The affected Fluvastatin capsules were repacked and distributed in Arizona, California, Oregon, and Washington. The specific pedigree code for the recalled Fluvastatin is 00378802077, and the expiration code is W002655. The potentially mislabeled Acetaminophen/Butalbital/Caffeine tablets have pedigree W002654 and an expiration date of 6/4/2014.
Patients and healthcare providers should verify the labeling of their medications. If you have Fluvastatin capsules with the specified pedigree and expiration codes, you should contact your pharmacist or healthcare provider for guidance on whether to continue using the medication or obtain a replacement.
The recalled product
- Product
- FLUVASTATIN, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378802077.
- 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)
- FLUVASTATIN
- Capsule
- 20 mg has the following codes: Pedigree: 00378802077
- EXP: W002655.
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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