Venlafaxine HCL Tablets Recalled for Potential Labeling Error
Aidapak Services is recalling Venlafaxine HCL 50 mg tablets because they may be mislabeled as sulfasalazine 500 mg.
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, but the source text describes a labeling mixup without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Aidapak Services, LLC is recalling Venlafaxine HCL Tablet, 50 mg, Rx only, NDC 23155024801. The recall is due to a labeling error where the product may be mislabeled as sulfasalazine, Tablet, 500 mg, NDC 00603580121.
The affected product is identified by the pedigree AD65475_22 and an expiration date of 5/28/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for this specific product and stop using it if the label indicates sulfasalazine or if the pedigree matches the recalled item. The FDA has classified this as a Class II recall.
The recalled product
- Product
- VENLAFAXINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155024801
- 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)
- VENLAFAXINE HCL Tablet
- 50 mg has the following code Pedigree: AD65475_22
- EXP
- 5/28/2014.
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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