The Recall Desk
SevereFDA (Drugs)·D-892-2014·Announced 2014-01-29

Thioridazine HCL Tablets Recalled for Potential Label Mixup

Aidapak Services, LLC is recalling Thioridazine HCL 50 mg tablets because they may have been mislabeled as Guanfacine HCl 1 mg tablets.

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 FDA classifies this recall as Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential mislabeling of prescription drugs which can lead to significant injury.

Plain-English summary

Aidapak Services, LLC is recalling Thioridazine HCL, Tablet, 50 mg (NDC 00378061601) due to a labeling error. The source text indicates that these tablets may have been mislabeled as Guanfacine HCl, Tablet, 1 mg (NDC 00591044401).

The recalled Thioridazine HCL tablets have the pedigree AD73525_28 and an expiration date of 5/30/2014. The potentially mislabeled Guanfacine HCl tablets have the pedigree AD73525_13 and an expiration date of 4/30/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers who possess these products should stop using them and contact their healthcare provider or pharmacist for guidance. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
THIORIDAZINE HCL, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378061601.
Affected units
100

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)

  • THIORIDAZINE HCL
  • Tablet
  • 50 mg has the following codes: Pedigree: AD73525_28
  • EXP: 5/30/2014.

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

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