The Recall Desk
SevereFDA (Drugs)·D-893-2014·Announced 2014-01-29

FDA Recalls Tizanidine Tablets Due to Potential Label Mixup

Aidapak Services, LLC is recalling Tizanidine HCl 2 mg tablets that may have been mislabeled as Niacin TR 500 mg.

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 severity score of 4 (Severe) per the rubric, as it involves a potential label mixup that could lead to incorrect medication administration.

Plain-English summary

Aidapak Services, LLC is recalling Tizanidine HCl, Tablet, 2 mg, NDC 00378072219, due to a potential label mixup. The recalled product may have been mislabeled as NIACIN TR, Tablet, 500 mg, NDC 00904434260. The affected Tizanidine tablets have pedigree W002975 and an expiration date of 6/11/2014.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA 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 Tizanidine HCl 2 mg tablets with pedigree W002975 and expiration date 6/11/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for credit.

The recalled product

Product
tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378072219.
Affected units
150

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)

  • tiZANidine HCl
  • Tablet
  • 2 mg has the following codes: Pedigree: W002975
  • EXP: 6/11/2014.

Distribution

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →