FDA Recalls Mislabelled Cetirizine HCL Tablets Distributed by Aidapak Services
Aidapak Services, LLC is recalling 5 mg Cetirizine HCL tablets that may have been mislabeled as 300 mg Lithium Carbonate ER 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, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (such as mislabeling a common antihistamine as a mood stabilizer) are rated as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 5 mg Cetirizine HCL tablets distributed by Aidapak Services, LLC. The recall is due to a labeling error where the tablets may have been mislabeled as 300 mg Lithium Carbonate ER tablets.
The affected product is identified by NDC 00378363501, pedigree AD32757_13, and expiration date 5/13/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The mislabeled product is identified by NDC 00054002125, pedigree AD39564_1, and expiration date 5/13/2014.
Consumers and healthcare providers should check their inventory for the specific pedigree and expiration date listed above. If the product is found, it should be returned to the distributor or a local pharmacy for disposal. Patients should consult their healthcare provider if they have taken the medication.
The recalled product
- Product
- CETIRIZINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378363501.
- 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)
- CETIRIZINE HCL
- Tablet
- 5 mg has the following codes: Pedigree: AD32757_13
- EXP: 5/13/2014.
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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