Promethazine HCL Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Promethazine HCL tablets that may be mislabeled as Cholecalciferol due to a labeling mixup.
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 2/5 (Moderate).
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 (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Aidapak Services, LLC is recalling Promethazine HCL, Tablet, 25 mg (NDC 65162052110) due to a labeling mixup. The recalled product may be potentially mislabeled as Cholecalciferol, Tablet, 400 units (NDC 00904582360). The specific pedigree for the recalled Promethazine is W002578, with an expiration date of 6/3/2014. The potentially mislabeled Cholecalciferol has pedigree W002574 and the same expiration date.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Promethazine HCL tablets with pedigree W002578 and expiration date 6/3/2014. If found, these products should be quarantined and returned to the distributor or manufacturer for credit.
The recalled product
- Product
- PROMETHAZINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162052110
- 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)
- PROMETHAZINE HCL
- Tablet
- 25 mg has the following code Pedigree: W002578
- EXP: 6/3/2014.
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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