foundmatterdb

Field reports on stuff that let you down

Medications

487 reports

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 43066-995-24. 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.

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Baxter Healthcare Corporation

Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48. 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.

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Baxter Healthcare Corporation

Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-9549-50. 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.

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Mylan Pharmaceuticals Inc

Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgan…

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Golden State Medical Supply Inc.

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30. Reason: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalledThe maker or a government agency pulled this product. Check the model or lot number and stop using it until it's fixed or refunded. due to failed dissolution Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide.

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · …

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Hikma Pharmaceuticals USA INC.

Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228. Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impu…

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nat…

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Lupin Pharmaceuticals Inc.

Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04. Reason: Failed content uniformity specifications. Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · USA Nationwide

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Mallinckrodt Hospital Products Inc.

Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2 Reason: Presence of particulate matter: glass and stopper piece Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · USA Nationwide

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Church & Dwight Co., Inc.

Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205. Reason: CGMP Deviations; FDAU.S. Food and Drug Administration. It handles food, drink, cosmetic and medication recalls. Learn more → inspection of the contract manufacturer noted out of limit results for microbiological testing Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Na…

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing …

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass I· Fresenius Kabi USA, LLC

Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20. Reason: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. Class IThe FDA's most serious recall level: a reasonable chance the product could cause serious health problems or death. · Ongoing · Nationwide in the USA

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass I· B BRAUN MEDICAL INC

Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00 Reason: Presence of Particulate matter. Class IThe FDA's most serious recall level: a reasonable chance the product could cause serious health problems or death. · Ongoing · U.S. Nationwide

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · …

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-17. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17. Reason: Subpotent Drug Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the United States

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

FDA recallMedicationsClass II· Apotex Corp.

Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 Reason: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nati…

Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

Report to FDAMedicationsReport to FDA

Illness reported after NORDIC NATURALS WOMEN'S MULTIVITAMIN ONE DAILY (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Malaise, Pharyngitis, Secretion discharge Outcome: Other Serious or Important Medical Event

flagged: Malaise, Pharyngitis, Secretion discharge
Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

Report to FDAMedicationsReport to FDA

Illness reported after ONE A DAY MENS COMPLETE MULTIVITAMIN (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Choking Outcome: Other Serious or Important Medical Event

flagged: Choking
Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

Report to FDAMedicationsReport to FDA

Illness reported after NUTRAFOL WOMENS BALANCE HAIR GROWTH NUTRACEUTICAL (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Drug-induced liver injury, Hepatic enzyme increased Outcome: Other Serious or Important Medical Event

flagged: Drug-induced liver injury, Hepatic enzyme increased
Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

Report to FDAMedicationsReport to FDA

Illness reported after BALANCE OF NATURE WHOLE PRODUCE FRUITS 90 CAPSULES, BALANCE OF NATURE WHOLE PRODUCE VEGGIES 90 CAPSULES (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Emergency care, Hospitalisation, Pain Outcome: Hospitalization, Other Serious or Important Medical Event

flagged: Emergency care, Hospitalisation, Pain
Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

Report to FDAMedicationsReport to FDA

Illness reported after PRESERVISION AREDS 2 FORMULA SOFT GELS (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Fatigue, Nausea, Vomiting Outcome: Disability

flagged: Fatigue, Nausea, Vomiting
Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280

Report to FDAMedicationsReport to FDA

Illness reported after PARATOXIL (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Hospitalisation, Nausea, Vomiting Outcome: Hospitalization, Other Serious or Important Medical Event

flagged: Hospitalisation, Nausea, Vomiting
Seen this too? Add your take
Add a sticker (optional)Stick one on:
0/280