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Recall Observatory FDA recall evidence

Drug product

ASCORBIC ACID, Tablet, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052260.

D-1018-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
3301 Tablets
Official record key
drug-enforcement:D-1018-2014

Official wording

Reason: Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD30024_1, EXP: 5/9/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_10, EXP: 9/23/2013; PIMOZIDE, Tablet, 2 mg, NDC 57844018701, Pedigree: AD30140_43, EXP: 5/7/2014; OMEGA-3-ACID ETHYL ESTERS, Capsu

Code information: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD30024_1, EXP: 5/9/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_10, EXP: 9/23/2013; PIMOZIDE, Tablet, 2 mg, NDC 57844018701, Pedigree: AD30140_43, EXP: 5/7/2014; OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: AD46265_43, EXP: 5/15/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, 0, NDC 00904531360, Pedigree: W003098, EXP: 6/13/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003718, EXP: 6/26/2014; QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W003825, EXP: 6/27/2014; BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, NDC 00603023516, Pedigree: AD42592_10, EXP: 5/14/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD73623_4, EXP: 5/30/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292055746, Pedigree: W002698, EXP: 6/5/2014; traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: AD21858_7, EXP: 5/1/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: AD30197_31, EXP: 5/9/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W003026, EXP: 6/12/2014.

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled