Venlafaxine HCL Tablets Recalled for Potential Label Mixup
Aidapak Services, LLC is recalling Venlafaxine HCL 100 mg tablets because they may have been mislabeled as other prescription drugs.
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, which corresponds to a Severe rating under the rubric, as the mislabeling of prescription drugs poses a significant risk of serious temporary or medically reversible health consequences.
Plain-English summary
Aidapak Services, LLC is recalling Venlafaxine HCL, Tablet, 100 mg, NDC 00093738301, due to a labeling error. The recall was initiated because the tablets may have been mislabeled as tiZANidine HCl, Tablet, 2 mg, or as other prescription medications including methylPREDNISolone and PROPRANOLOL HCL.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall covers specific pedigree codes and expiration dates, including AD73525_37 (EXP: 5/30/2014), AD42566_1 (EXP: 5/14/2014), and W002619 (EXP: 6/4/2014).
Consumers and healthcare providers should check their inventory for these specific NDC and pedigree codes. If the product is found, it should be returned to the distributor or the recalling firm, Aidapak Services, LLC, for credit.
The recalled product
- Product
- VENLAFAXINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738301.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 300
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
- Tablet
- 100 mg has the following codes: Pedigree: AD73525_37
- EXP: 5/30/2014
- Pedigree: AD42566_1
- EXP: 5/14/2014
- Pedigree: W002619
- EXP: 6/4/2014.
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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