Class II · Moderate risk
Guanfacine Extended-Release Tablets 2 mg
Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
guanFACINE HCl Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162071310
Affected NDC
65162-0713-10
Compare with the code on your package — it is the most precise check available.
Drug: Guanfacine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Guanfacine Hydrochloride Guanfacine NDC 65162-0713 |
HYDROCHLORIDE 2 mg/1 | Tablet Oral |
Amneal Pharmaceuticals LLC | Rx |
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-711-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Guanfacine recalls
See all
Class II · Moderate risk
guanFACINE HCl
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
Class II · Moderate risk
guanFACINE HC
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,
Other recalls by Aidapak Services, LLC
All 2013 recalls
Class II · Moderate risk
Methazolamide
Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the following drug: BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD39573_1, EXP: 5/13/2014.
Class II · Moderate risk
Perphenazine
Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD21790_28, EXP: 5/1/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W002730, EXP: 6/6/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: W003680, EXP: 6/25/2014; VENLAFAXINE HCL
Class II · Moderate risk
Trifluoperazine HCL
Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC 00115261101, Pedigree: AD52778_88, EXP: 5/21/2014.
Class II · Moderate risk
Cholecalciferol
Labeling: Label Mixup: CHOLECALCIFEROL, Tablet, 5000 units may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS ACIDOPHILUS, Capsule, 0 mg, NDC 54629011101, Pedigree: AD65311_7, EXP: 5/24/2014; QUINAPRIL HCL, Tablet, 20 mg, NDC 68180055809, Pedigree: W003556, EXP: 6/24/2014; POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, NDC 00486111101, Pedigree: AD52778_34, EXP: 5/20/2
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