Aidapak Recalls Torsemide Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Torsemide 10 mg tablets that may be mislabeled as Mexiletine HCl 200 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe rating under the rubric, particularly given the risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Torsemide Tablet, 10 mg, NDC 31722053001, due to a labeling error. The product may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC 00093874001.
The recalled Torsemide tablets have the pedigree AD25264_13 and an expiration date of 5/3/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722053001
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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 (3)
- TORSEMIDE Tablet
- 10 mg has the following code Pedigree: AD25264_13
- EXP: 5/3/2014.
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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