FDA Recalls Efavirenz Capsules Due to Potential Label Mixup
Aidapak Services is recalling Efavirenz 200 mg capsules because they may have been mislabeled as metformin HCl 500 mg tablets.
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 Efavirenz, Capsule, 200 mg (NDC 00056047492) due to a labeling error. The recall is classified as FDA Class II.
The issue involves a potential label mixup where the Efavirenz capsules may have been mislabeled as metformin HCl, Tablet, 500 mg (NDC 23155010201). Both products share the same expiration date of May 16, 2014, and similar pedigree codes (AD46312_31 for Efavirenz and AD46312_25 for metformin).
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received Efavirenz capsules that may be mislabeled as metformin.
The recalled product
- Product
- EFAVIRENZ, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00056047492.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Antiretroviral
- Hazard
- Affected units
- 90
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)
- EFAVIRENZ
- Capsule
- 200 mg has the following codes: Pedigree: AD46312_31
- EXP: 5/16/2014.
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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