FDA Recalls Mislabeled Darunavir Tablets Distributed by Aidapak Services
Aidapak Services is recalling Darunavir tablets that may be mislabeled as Hydrocodone/Acetaminophen. The error could lead to incorrect medication administration.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score per the rubric, as it involves a labeling error that could lead to incorrect medication use.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Darunavir Tablet, 800 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling mixup where the product may be mislabeled as Hydrocodone Bitartrate/Acetaminophen Tablet, 7.5 mg/325 mg.
The affected product is identified by NDC 59676056630, with pedigree W003929 and an expiration date of 7/1/2014. The mislabeled product is identified by NDC 52544016201, with pedigree W004005 and an expiration date of 7/1/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
This recall is classified as Class II because the mislabeling could result in a temporary or medically reversible adverse health consequence. Patients and healthcare providers should verify the correct medication before administration to avoid potential harm from taking the wrong drug.
The recalled product
- Product
- DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630
- 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)
- DARUNAVIR
- Tablet
- 800 mg has the following code Pedigree: W003929
- EXP: 7/1/2014.
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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