Aidapak Recalls RILUZOLE Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling RILUZOLE 50 mg tablets because they may have been mislabeled as LACTOBACILLUS 0 mg tablets.
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error (mislabeling) rather than a contamination or structural defect, and no illnesses or injuries are reported in the source text.
Plain-English summary
Aidapak Services, LLC is recalling RILUZOLE, Tablet, 50 mg (NDC 00075770060) due to a potential label mixup. The source text indicates that the RILUZOLE tablets may have been mislabeled as LACTOBACILLUS, Tablet, 0 mg (NDC 64980012950). The affected product is a prescription-only medication distributed by AidaPak Service, LLC.
The recall involves repacked drugs that were distributed in Arizona, California, Oregon, and Washington. The specific pedigree code for the recalled RILUZOLE is AD62992_11, with an expiration date of 5/23/2014. The mislabeled product is identified by pedigree AD62986_10, also with an expiration date of 5/23/2014.
Consumers and healthcare providers should check their inventory for RILUZOLE 50 mg tablets with the specified pedigree and expiration date. 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 for alternative treatment options if they have been prescribed this specific lot.
The recalled product
- Product
- RILUZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00075770060.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 120
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)
- RILUZOLE
- Tablet
- 50 mg has the following codes: Pedigree: AD62992_11
- EXP: 5/23/2014.
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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