The Recall Desk
ModerateFDA (Drugs)·D-501-2014·Announced 2014-01-22

Aidapak Recalls Omeprazole Capsules Due to Potential Labeling Mixup

Aidapak Services is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as Cyanocobalamin or Omega-3 fatty acid products.

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 and involves a labeling mixup, which fits the rubric for moderate severity involving minor labeling errors or low-risk contamination.

Plain-English summary

Aidapak Services, LLC is recalling Omeprazole/Sodium Bicarbonate capsules, 20 mg/1,100 mg, NDC 11523726503. The recall is due to a labeling mixup where the product may be potentially mislabeled as Cyanocobalamin tablets, 1000 mcg, NDC 00536355601, or Omega-3 fatty acid capsules, 1000 mg, NDC 00904404360.

The affected Omeprazole/Sodium Bicarbonate capsules have the following pedigree and expiration information: Pedigree W003789, EXP 6/27/2014, and Pedigree W003873, EXP 6/27/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for the specific NDC and pedigree numbers listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
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 (7)

  • OMEPRAZOLE/SODIUM BICARBONATE
  • Capsule
  • 20 mg/1
  • 100 mg has the following codes Pedigree: W003789
  • EXP: 6/27/2014
  • Pedigree: W003873
  • EXP: 6/27/2014.

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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