Aidapak Recalls Escitalopram Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling 5 mg Escitalopram tablets because they may have been mislabeled as Sodium Chloride 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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant harm (such as mislabeling a psychiatric medication as a saline tablet) are classified as Severe.
Plain-English summary
Aidapak Services, LLC is recalling 100-count bottles of 5 mg Escitalopram tablets (NDC 00093585001) due to a labeling error. The recall is initiated because the product may have been mislabeled as Sodium Chloride, Tablet, 1 gm (NDC 00223176001).
The affected product has the pedigree W003733 and an expiration date of 6/26/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers should check their medication for the specific NDC and pedigree listed above. If the product matches the description, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- ESCITALOPRAM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093585001.
- 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)
- ESCITALOPRAM
- Tablet
- 5 mg has the following codes: Pedigree: W003733
- EXP: 6/26/2014.
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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