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.
Medications
487 reports
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Seen this too? Add your take
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
Seen this too? Add your take
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
Seen this too? Add your take
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
Seen this too? Add your take
Illness reported after PRESERVISION AREDS 2 FORMULA SOFT GELS (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Fatigue, Nausea, Vomiting Outcome: Disability
Seen this too? Add your take
Illness reported after PARATOXIL (Vit/Min/Prot/Unconv Diet(Human/Animal)) Symptoms: Hospitalisation, Nausea, Vomiting Outcome: Hospitalization, Other Serious or Important Medical Event