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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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