Trazodone HCl Tablets Recalled Due to Potential Labeling Error
Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Amantadine HCl 100 mg.
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 error (label mixup) which is a minor labeling error with no reported illnesses or injuries, fitting the Moderate severity criteria.
Plain-English summary
Aidapak Services, LLC is recalling Trazodone HCl Tablet, 50 mg, Rx only, NDC 50111043303. The recall is due to a labeling error where the product may be mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100. The affected product has the pedigree AD54475_7 and an expiration date of 5/20/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The agency 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 Trazodone HCl 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 if they have questions about their medication.
The recalled product
- Product
- traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043303
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,000
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)
- traZODone HCl
- Tablet
- 50 mg has the following code Pedigree: AD54475_7
- EXP: 5/20/2014.
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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