FDA recall record

Aidapak Services FOLIC ACID, Tablet, 1 mg recall — FDA D-706-2014

Labeling:Label Mixup; FOLIC ACID, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree:…

Class IIclassification
D-706-2014official record ID
Jan 22, 2014report date

Recall record at a glance

Official recordD-706-2014
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmAidapak Services, LLC
Report dateJan 22, 2014
Recall initiation dateJul 2, 2013
Quantity1,000 Tablets
LocationVancouver, WA, United States

Official product description

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

Why the product was 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.

Distribution information

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Telephone.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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