The Recall Desk
SevereFDA (Drugs)·D-619-2014·Announced 2014-01-22

Aidapak Recalls Olanzapine Tablets Due to Potential Labeling Errors

Aidapak Services, LLC is recalling Olanzapine 7.5 mg tablets because they may be mislabeled as Levothyroxine or Mirtazapine. The repacked drugs were distributed in four western states.

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 classified this recall as Class II. According to the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), particularly given the risk of administering the wrong prescription medication.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Olanzapine 7.5 mg tablets (NDC 55111016530) due to a labeling mixup. The recall involves 210-tablet packages that were repacked and distributed in Arizona, California, Oregon, and Washington. The specific pedigree codes and expiration dates for the recalled Olanzapine are AD46265_46 (EXP: 5/15/2014), AD60272_79 (EXP: 5/22/2014), and AD73525_58 (EXP: 5/30/2014).

The hazard is that these Olanzapine tablets may be mislabeled as other prescription medications. Specifically, the source text indicates a potential mixup with Levothyroxine Sodium 175 mcg (Pedigree: AD46265_37, EXP: 5/15/2014), Levothyroxine Sodium 88 mcg (Pedigree: AD60272_73, EXP: 5/22/2014), and Mirtazapine 7.5 mg (Pedigree: AD73525_55, EXP: 5/30/2014). This mislabeling could lead to patients receiving the wrong medication.

The FDA has classified this recall as Class II, which means the 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 the specific NDC, pedigree codes, and expiration dates listed above. If found, these products should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111016530
Affected units
210

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 (8)

  • OLANZapine
  • Tablet
  • 7.5 mg has the following codes Pedigree: AD46265_46
  • EXP: 5/15/2014
  • Pedigree: AD60272_79
  • EXP: 5/22/2014
  • Pedigree: AD73525_58
  • 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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