Drug Enforcement D-789-2014

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014.

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.
Product quantity
400 Tablets
Reason for recall
Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) may be potentially mislabled as one of the following drugs: CYCLOBENZAPRINE HCL, Tablet, 5 mg, NDC 00591325601, Pedigree: AD73525_7, EXP: 5/30/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD21846_11, EXP: 5/1/2014.
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-789-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg) has the following codes: Pedigree: AD73525_16, EXP: 5/30/2014; Pedigree: AD21790_25, EXP: 5/1/2014.
More code info
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