Aidapak Recalls Ranolazine ER Tablets Due to Labeling Mixup
Aidapak Services is recalling RANOLAZINE ER 500 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
What this means for you
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 mixup, which is a significant risk but does not meet the criteria for Severe (Class I or structural defect) or High (high-risk pathogens).
Plain-English summary
Aidapak Services, LLC is recalling RANOLAZINE ER Tablet, 500 mg, Rx only, NDC 61958100301. The recall is due to a labeling mixup where the product may be mislabeled as other medications, including MELATONIN, DULoxetine HCl DR, OMEGA-3 FATTY ACID, and VALSARTAN. The affected product consists of 840 tablets per unit.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates for the affected lots are listed in the agency's recall notice. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare providers should check their inventory for RANOLAZINE ER 500 mg tablets with NDC 61958100301 and the specific pedigree codes listed in the recall notice. If found, the product should be quarantined and returned to the distributor or reported to the FDA. Patients should consult their healthcare provider if they have taken a medication that may have been mislabeled.
The recalled product
- Product
- RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 840
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 (18)
- RANOLAZINE ER
- Tablet
- 500 mg has the following codes Pedigree: AD23087_1
- EXP: 5/2/2014
- Pedigree: AD62995_7
- EXP: 5/29/2014
- Pedigree: W002857
- EXP: 6/7/2014
- Pedigree: W003538
- EXP: 6/21/2014
- Pedigree: W003741
- EXP: 6/26/2014
- Pedigree: AD32757_47
- EXP: 5/13/2014
- Pedigree: W003648
- EXP: 6/25/2014
- Pedigree: AD60272_40
- EXP: 5/22/2014.
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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