Aidapak Recalls Lorazepam Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Lorazepam tablets that may have been mislabeled as Tramadol HCl. The repacked drugs were distributed in four western states.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of administering the wrong medication (Lorazepam vs. Tramadol).
Plain-English summary
Aidapak Services, LLC is recalling Lorazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, due to a potential label mixup. The source text indicates that these tablets may have been mislabeled as traMADol HCl, Tablet, 25 mg (1/2 of 50 mg), NDC 57664037708. Both products share the same expiration date of May 22, 2014, but have different pedigree codes (AD60243_1 for Lorazepam and AD60272_92 for Tramadol).
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Lorazepam tablets with NDC 00591024001 and pedigree AD60243_1. If found, these products should be returned to the distributor or disposed of according to local regulations to prevent accidental administration of the wrong medication.
The recalled product
- Product
- LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00591024001.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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)
- LORazepam
- Tablet
- 0.25 mg (1/2 of 0.5 mg) has the following codes: Pedigree: AD60243_1
- EXP: 5/22/2014.
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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