Aidapak Recalls Tramadol Tablets Due to Potential Labeling Mixup
Aidapak Services, LLC is recalling 25 mg Tramadol HCl tablets that may be mislabeled as Levothyroxine Sodium 137 mcg.
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. Per the rubric, FDA Class II recalls with potential for significant harm (such as mislabeling a pain medication as a thyroid hormone) are rated as Severe (4).
Plain-English summary
Aidapak Services, LLC is recalling 200-tablet bottles of traMADol HCl Tablet, 25 mg (1/2 of 50 mg), NDC 57664037708. The recall is due to a labeling mixup where the product may be mislabeled as LEVOTHYROXINE SODIUM, Tablet, 137 mcg, NDC 00527163801. The affected product has the pedigree AD60272_92 and an expiration date of 5/22/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This is a Class II recall, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers should check their medication labels and discontinue use if the product matches the recalled description. They should contact their healthcare provider or pharmacist for guidance on proper medication management.
The recalled product
- Product
- traMADol HCl Tablet, 25 mg (1/2 of 50 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664037708
- 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)
- traMADol HCl
- Tablet
- 25 mg (1/2 of 50 mg) has the following code Pedigree: AD60272_92
- EXP: 5/22/2014.
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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