Venlafaxine HCL ER Capsules Recalled for Potential Label Mixup
Aidapak Services is recalling Venlafaxine HCL ER capsules due to a potential label mixup with other medications. The repacked drugs were distributed in four western states.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error (mislabeling) rather than a contamination or structural defect, and no injuries or illnesses are reported in the source text.
Plain-English summary
Aidapak Services, LLC is recalling Venlafaxine HCL ER, Capsule, 150 mg (NDC 00093738656) due to a labeling error. The recall is classified as FDA Class II. The issue involves a potential label mixup where the Venlafaxine capsules may have been mislabeled as Sotalol HCL, Cyanocobalamin, or Lanthanum Carbonate.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers specific pedigree codes and expiration dates, including AD30993_20 (EXP: 5/9/2014), W003084 (EXP: 6/12/2014), and W003414 (EXP: 6/19/2014).
Patients and healthcare providers should check their medication labels against the specific NDC and pedigree codes listed in the official recall notice. If the medication matches the recalled description, it should be returned to the pharmacy or distributor for replacement or refund.
The recalled product
- Product
- VENLAFAXINE HCL ER, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738656.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 120
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 (8)
- VENLAFAXINE HCL ER
- Capsule
- 150 mg has the following codes: Pedigree: AD30993_20
- EXP: 5/9/2014
- Pedigree: W003084
- EXP: 6/12/2014
- Pedigree: W003414
- EXP: 6/19/2014.
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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