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Research, guidelines, and safety alerts for your specialty.
Recent updates in Allergy & Immunology from the last 30 days.
Baxter Healthcare Corporation has issued a Class I recall for Dextrose Injection, USP, 70%, in 2000 mL bags (NDC 00338-0719-06). The recall was initiated because particulate matter identified as stainless steel particles was found in the solution.
Mylan Pharmaceuticals Inc has issued a Class II recall for Mycophenolate Mofetil for Injection, USP, 500 mg/vial (NDC 67457-386-81 carton, NDC 67457-386-00 vial), citing failed dissolution specifications. The affected product is sold as 4 single-dose vials manufactured for Mylan Institutional LLC and made in India.
Baxter Healthcare Corporation has issued a Class I recall for 0.9% Sodium Chloride Injection USP 500 mL in VIAFLEX plastic containers (NDC 0338-0049-03, 24 units per case) due to the presence of particulate matter identified as fiberglass. The FDA designates Class I recalls as involving products that could cause serious injury or death.
FDA has classified as Class I a recall of Glutathione 200 mg/mL, 30 mL sterile multidose vials manufactured by Optimal Balance Pharmacy in Houston, TX, intended for IM or IV injection. The recall states the action was due to microbial contamination of sterile products, with out-of-specification results obtained for bacterial endotoxin.
FDA reports a Class II recall of Broadway Joe's Pain Cream, a topical product containing Histamine Dihydrochloride 0.025%, 1500mg CBD Isolate, and 1000mg Hempseed oil, produced for Broadway Joe's of Franklin, TN. The recall, identified by NDC 83088-8120-5, was initiated due to CGMP deviations involving potential contamination of raw material used in the product.
Allies Group Inc. has recalled THE ONE SPF 50 Invisible Sunscreen Gel (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%) as a Class II recall. The company reports that firm testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
Allies Group Inc. has issued a Class II recall for THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, a single-use sachet product containing avobenzone, homosalate, octocrylene, and octisalate. The firm's testing indicated the affected product may not reliably provide the SPF 50 protection stated on its label, classifying it as a subpotent product.
Mallinckrodt Hospital Products Inc. issued a Class II recall for Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vials, NDC 63004-8710-1 and 63004-8710-2. The recall notice states the affected vials contain particulate matter identified as glass and stopper piece fragments.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, NDC 16729-447-17, manufactured by Intas Pharmaceuticals Limited. The recall notice cites the product as a subpotent drug.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), supplied in 1000-count bottles under NDC 16729-453-17. The product, manufactured by Intas Pharmaceuticals Limited in India, was recalled due to being subpotent.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), in 1000-count bottles, NDC 16729-448-17, manufactured by Intas Pharmaceuticals Limited in India. The recall reason listed is that the drug is subpotent.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), distributed in 90-count and 1000-count bottles (NDC 16729-457-15 and 16729-457-17). The product was manufactured by Intas Pharmaceuticals Limited in India and manufactured for Accord Healthcare in Raleigh, NC. The recall reason listed is that the drug is subpotent.
Fresenius Kabi USA has issued a Class I recall of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL) vials, NDC 65219-594-20, Rx Only. The company's internal investigation found the product to contain glass particulate matter, according to the recall notice.
