FDA recall record

Aidapak Services tiZANidine HCl Tablet, 2 mg recall — FDA D-621-2014

Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree: AD21790_37, EXP:…

Class IIclassification
D-621-2014official record ID
Jan 22, 2014report date

Recall record at a glance

Official recordD-621-2014
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmAidapak Services, LLC
Report dateJan 22, 2014
Recall initiation dateJul 2, 2013
Quantity600 Tablets
LocationVancouver, WA, United States

Official product description

tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915

Why the product was recalled

Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree: AD21790_37, EXP: 4/30/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD46257_59, EXP: 5/15/2014; NIACIN, Tablet, 100 mg, NDC 00904227160, Pedigree: W002661, EXP: 6/5/2014; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 00008060601, Pedigree

Distribution information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Telephone.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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