Desmopressin Acetate Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Desmopressin Acetate tablets because they may have been mislabeled as Loxapine 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 corresponds to a Moderate severity score when no specific hospitalizations or severe injuries are reported in the source text.
Plain-English summary
Aidapak Services, LLC is recalling Desmopressin Acetate, Tablet 0.1 mg (NDC 00591246401) due to a potential label mixup. The recalled product may have been mislabeled as Loxapine, Capsule, 5 mg (NDC 00591036901). The specific pedigree for the Desmopressin product is AD46426_16 with an expiration date of 5/15/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their medication labels to ensure they are taking the correct drug. If you have received Desmopressin Acetate tablets that are labeled as Loxapine, or vice versa, contact your pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- DESMOPRESSIN ACETATE, Tablet 0.1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591246401.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 98
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 (3)
- DESMOPRESSIN ACETATE
- Tablet 0.1 mg has the following codes: Pedigree: AD46426_16
- EXP: 5/15/2014.
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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