Rivaroxaban Tablets Recalled for Potential Venlafaxine Labeling Error
Aidapak Services is recalling Rivaroxaban 20 mg tablets that may be mislabeled as Venlafaxine HCL 100 mg due to a label mixup.
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, which corresponds to a Severe severity score under the rubric, particularly given the risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Rivaroxaban Tablet, 20 mg, NDC 50458057930, due to a potential labeling error. The recall is initiated because the product may be mislabeled as Venlafaxine HCL, Tablet, 100 mg, NDC 00093738301.
The affected product is identified by Pedigree W002620 and an expiration date of 6/4/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The agency has classified this recall as Class II.
Consumers and healthcare providers should check their inventory for Rivaroxaban 20 mg tablets with the specified pedigree and expiration date. If the product is found, it should be returned to the distributor or a pharmacy for replacement or refund. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- RIVAROXABAN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50458057930
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 30
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)
- RIVAROXABAN
- Tablet
- 20 mg has the following code Pedigree: W002620
- EXP: 6/4/2014.
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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