Key Takeaway

FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077. by Aidapak Services, LLC was recalled on July 2, 2013. The hazard: Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG,...

FDA Drug Class II Terminated

FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.

Recalled: July 2, 2013 ~270 Tablets units affected D-909-2014

Description

FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.

Hazard / Reason

Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG, NDC 64764024060, Pedigree: AD21790_46, EXP: 5/1/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: AD60272_55, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W002732, EXP: 6/6/2014.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.

Drugs

Company Information

Aidapak Services, LLC

Vancouver, WA, United States

View all 538 recalls by Aidapak Services, LLC →

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Related Recalls

FDA Drug Class II

IBUPROFEN, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67877029401

July 2, 2013
FDA Drug Class II

DOCUSATE CALCIUM, Capsule, 240 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375501.

July 2, 2013
FDA Drug Class II

CRANBERRY Tablet, 450 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896084501

July 2, 2013
FDA Drug Class II

PIROXICAM, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093075601.

July 2, 2013
FDA Drug Class II

PREGABALIN, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101268.

July 2, 2013
FDA Drug Class II

LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230

July 2, 2013

Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.