Metoprolol Tartrate Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Metoprolol Tartrate 25 mg tablets because they may have been mislabeled as Docusate Sodium 250 mg capsules.
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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling mixup, which fits the criteria for moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling Metoprolol Tartrate 25 mg tablets (NDC 00378001801) due to a potential labeling error. The recall was initiated because the tablets may have been mislabeled as Docusate Sodium 250 mg capsules (NDC 00536375710).
The affected product is identified by Pedigree W002535 and an expiration date of 6/3/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for the specific pedigree and expiration date listed. 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
- METOPROLOL TARTRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378001801.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 200
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)
- METOPROLOL TARTRATE
- Tablet
- 25 mg has the following codes: Pedigree: W002535
- EXP: 6/3/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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