The Recall Desk
ModerateFDA (Drugs)·D-502-2014·Announced 2014-01-22

FDA Recalls Omeprazole Capsules Due to Potential Label Mixup

Aidapak Services, LLC is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as other medications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a labeling error that could cause temporary or medically reversible health consequences. The rubric assigns a score of 2 for minor labeling errors and voluntary precautionary recalls.

Plain-English summary

Aidapak Services, LLC is voluntarily recalling Omeprazole/Sodium Bicarbonate, Capsule, 20 mg/1,110 mg (NDC 11523726503) due to a labeling error. The recall is initiated because the product may be potentially mislabeled as Acetaminophen, Chew Tablet, 80 mg; Lactobacillus GG, Capsule; or Mycophenolate Mofetil, Capsule, 250 mg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes and expiration dates: AD49399_4 (EXP: 5/16/2014), AD46300_17 (EXP: 5/15/2014), and AD65457_22 (EXP: 5/24/2014).

Consumers and healthcare providers should check their inventory for these specific NDCs and pedigree codes. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have taken a medication that may have been mislabeled.

The recalled product

Product
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
Affected units
294

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 (9)

  • OMEPRAZOLE/SODIUM BICARBONATE
  • Capsule
  • 20 mg/1
  • 110 mg has the following codes Pedigree: AD49399_4
  • EXP: 5/16/2014
  • Pedigree: AD46300_17
  • EXP: 5/15/2014
  • Pedigree: AD65457_22
  • EXP: 5/24/2014.

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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