FDA Recalls Mislabeled Acetaminophen, Butalbital, and Caffeine Tablets
Aidapak Services, LLC is recalling Acetaminophen/Butalbital/Caffeine tablets that may have been mislabeled as Aspirin. The error could cause patients to take the wrong medication.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the hazard involves a significant risk of harm such as taking the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Acetaminophen/Butalbital/Caffeine tablets (325 mg/50 mg/40 mg) that may have been mislabeled as Aspirin tablets (250 mg). The FDA has classified this recall as Class II, indicating a situation that may cause temporary or medically reversible adverse health consequences.
The affected product is identified by NDC 00603254421, Pedigree W002654, and an expiration date of 6/4/2014. The mislabeling error involved the product being labeled with the NDC 49348000123, Pedigree W002640, and expiration date 6/4/2014, which corresponds to Aspirin. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should verify the NDC and pedigree numbers on their medication packaging. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for replacement or refund. Patients should not take the medication until it has been verified as the correct product.
The recalled product
- Product
- ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603254421.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 100
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)
- ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE
- Tablet
- 325 mg/50 mg/40 mg has the following codes: Pedigree: W002654
- EXP: 6/4/2014.
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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