FDA Recalls Mislabelled Ibuprofen Tablets Distributed by Aidapak Services
Aidapak Services is recalling 400 mg ibuprofen tablets that may be mislabeled as 325 mg aspirin. The repacked drugs were distributed in four western states.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential mislabeling of prescription medications which can lead to significant injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Ibuprofen, Tablet, 400 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling mixup where the ibuprofen tablets may be mislabeled as Aspirin, Tablet, 325 mg. The affected product is identified by NDC 67877029401, Pedigree W002577, and an expiration date of 6/3/2014.
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 and healthcare providers should check their inventory for the specific pedigree and expiration date listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations to prevent accidental administration of the wrong medication.
The recalled product
- Product
- IBUPROFEN, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67877029401
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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)
- IBUPROFEN
- Tablet
- 400 mg has the following code Pedigree: W002577
- EXP: 6/3/2014.
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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