foundmatterdb

Field reports on stuff that let you down

Medications

487 reports

FDA drug shortageMedications· Somerset Therapeutics, LLC

Shortage: Bupivacaine Hydrochloride Injection — Bupivacaine Hydrochloride, Injection, 2.5 mg/1 mL (NDC 70069-752-25) Status: Current Used for: Anesthesia

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0718-12. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass I· OPTIMAL BALANCE PHARMACY

Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 Cypress Creek Pkwy Suite F, Houston, TX 77090 Reason: Microbial Contamination of Sterile Products - out of specifications results were obt…

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066-016-10. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass III· Supernus Pharmaceuticals, Inc.

Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30. Reason: Failed dissolution specifications. Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · US Nationwide.

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FDA recallMedicationsClass III· American Health Packaging

Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11). Reason: Labeling: Label Mix-up Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · US Nationwide.

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FDA recallMedicationsClass II· Teva Pharmaceuticals USA, Inc

traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01 Reason: Presence of Foreign Tablets/Capsules Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · U.S. Nationwide

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FDA recallMedicationsClass I· Baxter Healthcare Corporation

0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03 Reason: Presence of particulate matter: Particulates identified as fiberglass Class IThe FDA's most serious recall level: a reasonable chance the product could cause serious health problems or death. · Ongoing · Natonwide in the USA

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FDA recallMedicationsClass II· Allies Group Inc.

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914.UPC 8 885014 073293 Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection s…

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FDA recallMedicationsClass II· Allies Group Inc.

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853 Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.…

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-9648-12. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Lexia LLC

Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7 Reason: CGMP Deviations: Potential contamination of raw material Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Distributed in the state of Colorado (US).

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0714-24. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 43066-360-20. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Allies Group Inc.

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224 Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label. Cl…

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Allies Group Inc.

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 074733 Reason: Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the lab…

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4114-50. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Lexia LLC

Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4 Reason: CGMP Deviations: Potential contamination of raw material Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Distributed in the state of Colorado (US).

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FDA recallMedicationsinsulinAlternatives →Class II· Baxter Healthcare Corporation

MYXREDLIN, Insulin2 reports about insulin on this site. See them all → Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass III· Bionpharma Inc.

Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20. Reason: Presence of Foreign Tablets/Capsules Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · US Nationwide.

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Baxter Healthcare Corporation

Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12. Reason: CGMP Deviations Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide; Puerto Rico; and Chile.

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FDA recallMedicationsClass II· Sage Products, LLC

2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26 Reason: Cross Contamination with Other Products Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide.

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FDA recallMedicationsClass III· Chiesi USA, Inc.

Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01 Reason: Failed Stability Specifications: Out of specification stability result for the protein concentration profile. Class IIIThe lowest FDA recall level: unlikely to cause health problems, but it breaks the rules. · Ongoing · MO, TN

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FDA recallMedicationsClass II· Mylan Pharmaceuticals Inc

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93. Reason: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the U.S

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