Product Recalls in Montana

Product recalls affecting Montana — including food, drugs, consumer products, medical devices, and vehicles distributed to Montana. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,552 recalls have been distributed to Montana in the last 12 months.

48,326 total recalls
2,552 in last 12 months

Showing 38413860 of 13,407 recalls

DrugAugust 13, 2021· First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Recalled Item: MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV Recalled by First Royal Care Co. LLC,...

The Issue: Lack of Assurance of Sterility: FDA inspection raised sterility assurance...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Recalled Item: ACETYLCYSTEINE 2% OPTH SOLN Recalled by First Royal Care Co. LLC, dba Red...

The Issue: Lack of Assurance of Sterility: FDA inspection raised sterility assurance...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Recalled Item: LEVOCARNITINE 100MG/ML MDV SOLN Recalled by First Royal Care Co. LLC, dba...

The Issue: Lack of Assurance of Sterility: FDA inspection raised sterility assurance...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Recalled Item: MIC/B12A 25/50/50MG/ML 1MG/ML MDV Recalled by First Royal Care Co. LLC, dba...

The Issue: Lack of Assurance of Sterility: FDA inspection raised sterility assurance...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 0.5mg Recalled by Pfizer Inc. Due to CGMP...

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 1 mg Recalled by Pfizer Inc. Due to CGMP...

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 0.5mg/1mg Recalled by Pfizer Inc. Due to CGMP...

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 1 mg Recalled by Pfizer Inc. Due to CGMP...

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Akorn, Inc.

Recalled Item: Betamethasone Dipropionate Lotion USP (Augmented) Recalled by Akorn, Inc....

The Issue: Failed impurities/degradation specification: Out of Specification for an...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· SigmaPharm Laboratories LLC

Recalled Item: Sodium Phenylbutyrate POWDER Recalled by SigmaPharm Laboratories LLC Due to...

The Issue: Failed Impurities Specifications: Out of Specification impurity results...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Zydus Pharmaceuticals (USA) Inc

Recalled Item: Carvedilol Tablets Recalled by Zydus Pharmaceuticals (USA) Inc Due to...

The Issue: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 11, 2021· Ebay Seller - John Nguyen

Recalled Item: Hydro Pinapple Burn Max Health Thach Dua Recalled by Ebay Seller - John...

The Issue: Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine

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

Class I — Serious Health HazardOngoing
Refund
DrugAugust 10, 2021· SterRx, LLC

Recalled Item: Sodium Bicarbonate in 5% Dextrose Injection Recalled by SterRx, LLC Due to...

The Issue: Non-Sterility: firm's third party lab confirmed microbial contamination.

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

Class I — Serious Health HazardOngoing
Refund
DrugAugust 10, 2021· SterRx, LLC

Recalled Item: Sodium Bicarbonate in 5% Dextrose Injection Recalled by SterRx, LLC Due to...

The Issue: Lack of Assurance of Sterility

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 6, 2021· XELLIA PHARMACEUTICALS USA, LLC

Recalled Item: Micafungin for Injection Recalled by XELLIA PHARMACEUTICALS USA, LLC Due to...

The Issue: Labeling; Incorrect or Missing Package Insert: The package insert provided...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 6, 2021· XELLIA PHARMACEUTICALS USA, LLC

Recalled Item: Micafungin for Injection Recalled by XELLIA PHARMACEUTICALS USA, LLC Due to...

The Issue: Labeling; Incorrect or Missing Package Insert: The package insert provided...

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 5, 2021· Hikma Pharmaceuticals USA Inc.

Recalled Item: Bleomycin for Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to...

The Issue: Labeling: Not elsewhere classified: Mislabeling

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

Class III — Low RiskOngoing
Refund
DrugAugust 5, 2021· DuPont Nutrition USA, Inc

Recalled Item: Avicel Recalled by DuPont Nutrition USA, Inc Due to Out of specification...

The Issue: Out of specification results for conductivity.

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

Class III — Low RiskOngoing
Refund
DrugAugust 3, 2021· The Harvard Drug Group

Recalled Item: Fexofenadine Hydrochloride Tablets Recalled by The Harvard Drug Group Due to...

The Issue: Failed Impurities/Degradation Specifications

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

Class II — Potential Health HazardOngoing
Refund
DrugAugust 3, 2021· Teligent Pharma, Inc.

Recalled Item: Lidocaine Hydrochloride Topical Solution Recalled by Teligent Pharma, Inc....

The Issue: Superpotent Drug

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

Class I — Serious Health HazardOngoing
Refund