FDA Recalls Omeprazole Capsules Due to Potential Labeling Mixup
Aidapak Services is recalling Omeprazole/Sodium Bicarbonate capsules because they may be mislabeled as Benzocaine/Menthol lozenges. The FDA classifies this as a Class II recall.
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 due to a labeling mixup. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.
Plain-English summary
Aidapak Services, LLC is recalling Omeprazole/Sodium Bicarbonate capsules, 20 mg/110 mg, NDC 11523726503. The recall is due to a labeling mixup where the product may be mislabeled as Benzocaine/Menthol lozenges, 15 mg/2.6 mg, NDC 63824073116. The affected product has the pedigree AD42584_15 and an expiration date of 5/14/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, which indicates a situation that might temporarily cause or present a reasonable probability of serious adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. 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 questions regarding their medication.
The recalled product
- Product
- OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 84
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 (4)
- OMEPRAZOLE/SODIUM BICARBONATE
- Capsule
- 20 mg/110 mg has the following code Pedigree: AD42584_15
- EXP: 5/14/2014.
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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