FDA Recalls FIDAXOMICIN Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling FIDAXOMICIN 200 mg tablets that may be mislabeled as BENAZEPRIL HCL 40 mg. The error affects repacked drugs 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 drugs which could lead to incorrect treatment.
Plain-English summary
Aidapak Services, LLC is recalling FIDAXOMICIN Tablet, 200 mg, NDC 52015008001, due to a labeling error. The product may be mislabeled as BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410. The specific pedigree number for the affected FIDAXOMICIN is W003920, with an expiration date of 6/28/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, indicating a situation that might temporarily cause or present a slight probability of serious adverse health consequences.
Healthcare providers and patients should check their inventory and prescriptions for FIDAXOMICIN tablets with pedigree W003920. If the product is found, it should be returned to the distributor or a local pharmacy for disposal or replacement. Patients should not take the medication if they suspect a labeling error and should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001
- 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)
- FIDAXOMICIN
- Tablet
- 200 mg has the following code Pedigree: W003920
- EXP: 6/28/2014.
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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