FDA Recalls Estradiol Tablets Due to Potential Labeling Error
Aidapak Services, LLC is recalling Estradiol 0.5 mg tablets because they may have been mislabeled as Nicotine Polacrilex gum.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they represent a potential for adverse health consequences.
Plain-English summary
Aidapak Services, LLC is recalling Estradiol, Tablet, 0.5 mg, NDC 00555089902, because the product may have been mislabeled as Nicotine Polacrilex, Gum, 2 mg. The FDA has classified this recall as Class II, indicating a situation that could temporarily cause adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected Estradiol tablets have the pedigree AD30993_11 and an expiration date of 5/9/2014. The potentially mislabeled product was distributed in Arizona, California, Oregon, and Washington. The source text does not specify the exact number of units recalled or the specific dates of distribution.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The recall is limited to the specific lot identified by the pedigree and expiration date listed above.
The recalled product
- Product
- ESTRADIOL, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555089902.
- 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)
- ESTRADIOL
- Tablet
- 0.5 mg has the following codes: Pedigree: AD30993_11
- EXP: 5/9/2014.
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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