Drug Enforcement D-955-2014

Labeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30028_34, EXP: 5/7/2014; HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, NDC 00574024701, Pedigree: W003614, EXP: 6/25/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
CALCIUM ACETATE, Tablet, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00574011302.
Product quantity
401 Tablets
Reason for recall
Labeling: Label Mixup: CALCIUM ACETATE, Tablet, 667 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD30028_34, EXP: 5/7/2014; HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, NDC 00574024701, Pedigree: W003614, EXP: 6/25/2014.
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-955-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
CALCIUM ACETATE, Tablet, 667 mg has the following codes: Pedigree: AD23098_1, EXP: 5/8/2014; Pedigree: W003637, EXP: 6/25/2014.
More code info