Agency classClass IIOur severity:Moderate FDA (Drugs)·D-667-2014·Announced 2014-01-22

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.

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 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: mis-labeling
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

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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Same hazard · mis labeling