FDA Recalls Mislabeled Guaifenesin Tablets Distributed by Aidapak Services
Aidapak Services is recalling 200 mg Guaifenesin tablets that may be mislabeled as Pancrelipase DR capsules. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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 2/5 (Moderate).
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 due to a labeling mixup. Per the rubric, minor labeling errors and low-risk contamination fall under the Moderate severity category, as no specific injuries or illnesses are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Guaifenesin, Tablet, 200 mg, distributed by Aidapak Services, LLC. The recall is due to a labeling error where the product may be mislabeled as Pancrelipase DR, Capsule, 24000 /76000 /120000 USP units.
The affected product is identified by NDC 00904515460, Pedigree W002853, and an expiration date of 6/7/2014. 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 product codes listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding the medication they have received.
The recalled product
- Product
- GUAIFENESIN, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904515460
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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)
- GUAIFENESIN
- Tablet
- 200 mg has the following code Pedigree: W002853
- EXP: 6/7/2014.
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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