The Recall Desk
SevereFDA (Drugs)·D-632-2014·Announced 2014-01-22

FDA Recalls Pimozide Tablets Due to Potential Metoprolol Labeling Error

Aidapak Services is recalling Pimozide 1 mg tablets that may be mislabeled as Metoprolol Tartrate 12.5 mg. The error poses a risk of incorrect medication administration.

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, and the rubric specifies that FDA Class II recalls with potential for significant harm (such as medication mix-ups) are rated as Severe (4).

Plain-English summary

Aidapak Services, LLC is recalling Pimozide Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, due to a labeling mixup. The recalled product may be potentially mislabeled as Metoprolol Tartrate, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901.

The affected Pimozide tablets have the pedigree AD73525_61 and an expiration date of 5/30/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The mislabeling could result in patients receiving the wrong medication, as Pimozide and Metoprolol Tartrate are distinct drugs with different therapeutic uses and dosages.

Healthcare providers and patients should check their inventory for Pimozide tablets with the specified pedigree and expiration date. If the product is found, it should be quarantined and returned to the distributor or manufacturer. Patients should consult their healthcare provider if they have taken the medication to ensure they are receiving the correct treatment.

The recalled product

Product
PIMOZIDE Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57844018701
Affected units
200

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)

  • PIMOZIDE
  • Tablet
  • 1 mg (1/2 of 2 mg) has the following code Pedigree: AD73525_61
  • EXP: 5/30/2014.

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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