FDA Recalls Mislabeled Mesalamine DR Capsules Due to Label Mixup
Aidapak Services, LLC is recalling Mesalamine DR capsules that may have been mislabeled as Chlorophyllin Copper Complex tablets.
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 the product may cause temporary or medically reversible health consequences. The hazard is a label mixup, which is a labeling error rather than a contamination or structural defect.
Plain-English summary
Aidapak Services, LLC is recalling Mesalamine DR, Capsule, 400 mg, NDC 00430075327, due to a labeling error. The recall was initiated because the product may have been mislabeled as Chlorophyllin Copper Complex, Tablet, 100 mg, NDC 11868000901.
The affected product is a prescription-only medication distributed in Arizona, California, Oregon, and Washington. The specific lot identified in the recall has a pedigree of AD34934_1 and an expiration date of 1/31/2014. The quantity per package is 180 capsules.
Consumers and healthcare providers should check their inventory for Mesalamine DR capsules with the specified pedigree and expiration date. 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
- MESALAMINE DR, Capsule, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00430075327.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 180
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)
- MESALAMINE DR
- Capsule
- 400 mg has the following codes: Pedigree: AD34934_1
- EXP: 1/31/2014.
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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