The Recall Desk
SevereFDA (Drugs)·D-596-2014·Announced 2014-01-22

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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