FDA Recalls Omeprazole Capsules Due to Potential Labeling Mixup
Aidapak Services is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as Lactobacillus GG or Pyridoxine HCL.
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 without reported illness.
Plain-English summary
Aidapak Services, LLC is recalling Omeprazole/Sodium Bicarbonate capsules, 20 mg/1110 mg, NDC 11523726503. The recall is due to a labeling mixup where the product may be mislabeled as Lactobacillus GG capsules or Pyridoxine HCL tablets.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are listed in the agency's recall notice. No illnesses or injuries have been reported in connection with this recall.
Consumers should check their medication for the specific NDC and pedigree codes listed in the recall notice. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the medication.
The recalled product
- Product
- OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 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 (6)
- OMEPRAZOLE/SODIUM BICARBONATE
- Capsule
- 20 mg/1110 mg has the following codes Pedigree: AD70655_20
- EXP: 5/29/2014
- Pedigree: AD73627_35
- EXP: 5/30/2014.
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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