FDAClass IIJanuary 22, 2014

Folic Acid recall: Labeling Error

FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162036110

Why was Folic Acid recalled?

Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD32328_5, EXP: 5/9/2014; DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W003821, EXP: 6/27/2014; ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: W003096, EXP: 6/13/2014.

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?

FOLIC ACID, Tablet, 1 mg has the following codes Pedigree: AD33897_22, EXP: 5/9/2014; Pedigree: W003822, EXP: 6/27/2014; Pedigree: W003097, EXP: 6/13/2014.

Product
FOLIC ACID, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162036110
Recalling firm
Aidapak Services, LLC
Quantity
1,000 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls