Product Recalls in Hawaii

Product recalls affecting Hawaii — including food, drugs, consumer products, medical devices, and vehicles distributed to Hawaii. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,562 recalls have been distributed to Hawaii in the last 12 months.

47,764 total recalls
2,562 in last 12 months

Showing 49014920 of 13,429 recalls

DrugNovember 20, 2019· AuroMedics Pharma LLC

Recalled Item: Mirtazapine Tablets Recalled by AuroMedics Pharma LLC Due to Labeling: Label...

The Issue: Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugNovember 20, 2019· AuroMedics Pharma LLC

Recalled Item: Mirtazapine Tablets Recalled by AuroMedics Pharma LLC Due to Labeling: Label...

The Issue: Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugNovember 20, 2019· American Health Packaging

Recalled Item: Ranitidine Tablets Recalled by American Health Packaging Due to CGMP...

The Issue: CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 20, 2019· Idelle Labs

Recalled Item: SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant...

The Issue: Labeling Product Contains Undeclared API: Active Ingredient on label is not...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 20, 2019· Idelle Labs

Recalled Item: SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net...

The Issue: Labeling Product Contains Undeclared API: Active Ingredient on label is not...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 20, 2019· Idelle Labs

Recalled Item: SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant...

The Issue: Labeling Product Contains Undeclared API: Active Ingredient on label is not...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 19, 2019· Baxter Healthcare Corporation

Recalled Item: 0.9% Sodium Chloride Irrigation USP 5000 mL bags Recalled by Baxter...

The Issue: Lack of Assurance of Sterility: Product has the potential to leak.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 19, 2019· AuroMedics Pharma LLC

Recalled Item: Gabapentin Capsules Recalled by AuroMedics Pharma LLC Due to Presence of...

The Issue: Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 15, 2019· Rising Pharmaceuticals, Inc.

Recalled Item: Timolol Maleate Sterile Opthalmic Solution Recalled by Rising...

The Issue: Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 15, 2019· Rising Pharmaceuticals, Inc.

Recalled Item: Timolol Maleate USP Recalled by Rising Pharmaceuticals, Inc. Due to...

The Issue: Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 15, 2019· Akorn, Inc.

Recalled Item: MYORISAN (isotretinoin capsules Recalled by Akorn, Inc. Due to Unit Dose...

The Issue: Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 15, 2019· Grato Holdings, Inc.

Recalled Item: Colostat Recalled by Grato Holdings, Inc. Due to Labeling mix-up -...

The Issue: Labeling mix-up - Indications on product label are incorrect.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 15, 2019· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Clobetasol Propionate Foam Recalled by Glenmark Pharmaceuticals Inc., USA...

The Issue: Defective delivery system; product is not foaming or is coming out as liquid.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 15, 2019· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Clobetasol Propionate Foam (Emulsion Formulation) Recalled by Glenmark...

The Issue: Defective delivery system; product is not foaming or is coming out as liquid.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugNovember 14, 2019· AVKARE Inc.

Recalled Item: AVKARE Ranitidine Tablets Recalled by AVKARE Inc. Due to CGMP Deviations:...

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 14, 2019· AVKARE Inc.

Recalled Item: AVKARE Ranitidine Tablets Recalled by AVKARE Inc. Due to CGMP Deviations:...

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 13, 2019· Precision Dose Inc.

Recalled Item: Ranitidine Oral Solution Recalled by Precision Dose Inc. Due to CGMP...

The Issue: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 13, 2019· Natures Rx

Recalled Item: Silver Bullet Recalled by Natures Rx Due to Undeclared Active

The Issue: Marketed Without an Approved NDA/ANDA; Product contains undeclared active...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugNovember 12, 2019· Integrated Health Concepts Inc. dba Conversio Health

Recalled Item: Albuterol 2.5mg / Ipratropium 0.75mg /Budesonide 0.25mg Recalled by...

The Issue: Lack of Processing Controls

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugNovember 12, 2019· QuVa Pharma, Inc.

Recalled Item: fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 Recalled by QuVa...

The Issue: Presence of Particulate matter: manufacturer recalled fentanyl API due to...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund