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 41014120 of 48,326 recalls

Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2024· King Systems Corp. dba Ambu, Inc.

Recalled Item: KING LTSD Recalled by King Systems Corp. dba Ambu, Inc. Due to Exceed the...

The Issue: Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Thiamine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius Kabi...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP Recalled...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP Recalled by...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP Recalled by...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: EPINEPHrine 0.9% Sodium Chloride Injection USP Recalled by Fresenius Kabi...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Oxytocin 0.9% Sodium Chloride Injection USP Recalled by Fresenius Kabi...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: CGMP violations

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 25, 2024· Fresenius Kabi Compounding, LLC

Recalled Item: Phenylephrine HCl 0.9% Sodium Chloride Injection USP Recalled by Fresenius...

The Issue: cGMP violations

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 25, 2024· Cardinal Health 200, LLC

Recalled Item: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack...

The Issue: Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 25, 2024· Biocare Medical, LLC

Recalled Item: intelliPATH Universal HRP Detection Kit Recalled by Biocare Medical, LLC Due...

The Issue: Kits containing the DAB chromogen buffer, intended for use in either manual...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
DrugSeptember 24, 2024· Nivagen Pharmaceuticals Inc

Recalled Item: Atorvastatin Calcium Tablets Recalled by Nivagen Pharmaceuticals Inc Due to...

The Issue: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400...

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

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 24, 2024· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray...

The Issue: Defective Delivery System: The dip tube is clogged causing the spray not to...

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

Class II — Potential Health HazardOngoing
Refund