Drug Enforcement D-903-2014

Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 11845014882, Pedigree: AD70700_7, EXP: 5/29/2014; TACROLIMUS, Capsule, 0.5 mg, NDC 00781210201, Pedigree: W003169, EXP: 6/13/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD42584_1, EXP: 5/14/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
ATORVASTATIN CALCIUM, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378212277.
Product quantity
270 Tablets
Reason for recall
Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 11845014882, Pedigree: AD70700_7, EXP: 5/29/2014; TACROLIMUS, Capsule, 0.5 mg, NDC 00781210201, Pedigree: W003169, EXP: 6/13/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD42584_1, EXP: 5/14/2014.
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-903-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
ATORVASTATIN CALCIUM, Tablet, 80 mg has the following codes: Pedigree: AD73627_1, EXP: 5/30/2014; Pedigree: W003213, EXP: 6/14/2014; Pedigree: AD46300_1, EXP: 5/15/2014.
More code info
—