FDA Recalls GuaiFENesin ER Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling GuaiFENesin ER tablets because they may be mislabeled as Omega-3 acid ethyl esters capsules.
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, which aligns with the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling GuaiFENesin ER Tablets, 600 mg, NDC 63824000850, due to a labeling mixup. The recall involves 500-tablet units with pedigree W003244 and an expiration date of 6/17/2014.
The FDA classifies this as a Class II recall because the GuaiFENesin ER tablets may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, with pedigree W003243 and an expiration date of 6/17/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Patients and healthcare providers should verify the product labeling and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 500
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)
- guaiFENesin ER
- Tablet
- 600 mg has the following code Pedigree: W003244
- EXP: 6/17/2014.
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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