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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 241–260 of 1,000 recalls

Class IITerminated

Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Lack of Assurance of Sterility

October 2, 2023 · DrugView details →

Class IITerminated

Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Lack of Assurance of Sterility

October 2, 2023 · DrugView details →

Class IITerminated

Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Lack of Assurance of Sterility

October 2, 2023 · DrugView details →

Class IITerminated

Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Lack of Assurance of Sterility

October 2, 2023 · DrugView details →

Class IITerminated

Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

Microbial contamination of Non-Sterile Products

September 29, 2023 · DrugView details →

Class IITerminated

ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA

Biomic Sciences, LLC dba ION Intelligence of Nature

Microbial contamination of Non-Sterile Products

September 29, 2023 · DrugView details →

Class IITerminated

fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

Zydus Pharmaceuticals (USA) Inc

Failed Dissolution Specifications

September 21, 2023 · DrugView details →

Class IITerminated

PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-6007-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

Class IITerminated

ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1

Central Admixture Pharmacy Services Inc

Lack of assurance of sterility:

September 21, 2023 · DrugView details →

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