US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

guanFACINE HCl

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Label Mixup: guanFACINE HCl, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: W002727, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: AD39588_7, EXP: 5/13/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, NDC 11523726503, Pedigree: W003873, EXP: 6/2

What was recalled

guanFACINE HCl, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591044401.

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-965-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Guanfacine recalls

See all
Class II · Moderate risk Ongoing

Guanfacine Extended-Release Tablets 2 mg

Reason Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

Apotex Corp. NDC 60505-3928-1 D-0324-2021
Class II · Moderate risk Terminated

guanFACINE HC

Reason Labeling: Label Mixup: guanFACINE HC, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD46265_22, EXP: 5/15/2014; FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 60505251002, Pedigree: AD46414_19, EXP: 5/16/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70629_4, EXP: 5/29/2014; guanFACINE HCl,

Aidapak Services, LLC D-895-2014
Class II · Moderate risk Terminated

guanFACINE HCl Tablet

Reason Labeling:Label Mixup; guanFACINE HCl Tablet, 2 mg may be potentially mislabeled as buPROPion HCl ER, Tablet, 200 mg, NDC 47335073886, Pedigree: AD21790_4, EXP: 5/1/2014; AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002997, EXP: 6/11/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: W003677, EXP: 2/28/2014; ACYCLOVIR, Capsule, 200 mg, NDC 00093894001, Pedigree: AD60

Aidapak Services, LLC D-711-2014