FDAClass IIJanuary 29, 2014

Lithium Carbonate ER recall: Labeling Error

LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.

Why was Lithium Carbonate ER recalled?

Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LITHIUM CARBONATE ER, Tablet, 450 mg has the following codes: Pedigree: AD21790_28, EXP: 5/1/2014 Pedigree: AD46265_10, EXP: 5/15/2014 Pedigree: W002730, EXP: 6/6/2014 Pedigree: W003681, EXP: 6/25/2014 Pedigree: AD60272_25, EXP: 5/22/2014 Pedigree: AD62796_1, EXP: 5/22/2014 Pedigree: W003327, EXP: 6/19/2014.

Product
LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.
Recalling firm
Aidapak Services, LLC
Quantity
1899 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls