Drug Enforcement D-612-2014

Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600 mg, NDC 00228263611, Pedigree: AD21965_7, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD70629_19, EXP: 5/29/2014; SODIUM BICARBONATE, Tablet, 650 mg, NDC 64980018210, Pedigree: W002970, EXP: 6/11/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
TRIMETHOBENZAMIDE HCl Capsule, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 53489037601
Product quantity
300 Capsules
Reason for recall
Labeling: Label Mixup; TRIMETHOBENZAMIDE HCl, Capsule, 300 mg may be potentially mislabeled as GABAPENTIN, Tablet, 600 mg, NDC 00228263611, Pedigree: AD21965_7, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 5000 units, NDC 00904598660, Pedigree: AD70629_19, EXP: 5/29/2014; SODIUM BICARBONATE, Tablet, 650 mg, NDC 64980018210, Pedigree: W002970, EXP: 6/11/2014.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-612-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
TRIMETHOBENZAMIDE HCl, Capsule, 300 mg has the following codes Pedigree: AD21858_10, EXP: 5/1/2014; Pedigree: AD70625_1, EXP: 5/29/2014; Pedigree: W002976, EXP: 6/11/2014.
More code info