FDA Recalls MEXILETINE HCL Capsules Due to Potential Labeling Error
Aidapak Services, LLC is recalling MEXILETINE HCL capsules because they may have been mislabeled as CALCIUM ACETATE. The error could lead to patients receiving the wrong medication.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the hazard involves a significant risk of harm such as receiving the wrong medication, even if specific injury reports are not detailed in the provided text.
Plain-English summary
Aidapak Services, LLC is recalling MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, due to a potential labeling error. The source text indicates that these capsules may have been mislabeled as CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826. Both products share the same expiration date of 5/23/2014, but the pedigree codes differ (AD62865_7 for MEXILETINE and AD62865_4 for CALCIUM ACETATE).
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients and healthcare providers should verify the label of their MEXILETINE HCL capsules against the NDC number 00093873901 and pedigree AD62865_7. If the label indicates CALCIUM ACETATE or if there is any uncertainty regarding the product identity, the medication should not be used and the distributor or pharmacist should be contacted for replacement or disposal instructions.
The recalled product
- Product
- MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093873901.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 100
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)
- MEXILETINE HCL
- Capsule
- 150 mg has the following codes: Pedigree: AD62865_7
- EXP: 5/23/2014.
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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