FDA Recalls Esterified Estrogens Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling Esterified Estrogens tablets because they may be mislabeled as Etodolac. The repacked drugs were distributed in four western states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Aidapak Services, LLC is recalling Esterified Estrogens Tablets, 0.625 mg, NDC 61570007301, due to a labeling mixup. The affected product may be potentially mislabeled as Etodolac, Tablet, 400 mg, NDC 51672401801. The specific pedigree for the recalled Esterified Estrogens is W003736, with an expiration date of 6/26/2014.
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.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be returned to the distributor or the recalling firm, Aidapak Services, LLC, for appropriate handling.
The recalled product
- Product
- ESTERIFIED ESTROGENS Tablet, 0.625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61570007301
- 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 (4)
- ESTERIFIED ESTROGENS
- Tablet
- 0.625 mg has the following code Pedigree: W003736
- EXP: 6/26/2014.
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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