Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Endocrinology from the last 30 days.
FDA states Baxter Healthcare Corporation has issued a Class I recall for Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06), citing the presence of particulate matter identified as stainless steel particles in the solution. The recall is classified as Class I, the FDA's designation for situations where use of the product may cause serious injury or death.
Baxter Healthcare Corporation has issued a Class I recall for 0.9% Sodium Chloride Injection USP 500 mL VIAFLEX plastic containers (NDC 0338-0049-03), citing the presence of particulate matter identified as fiberglass. The recall notice does not specify additional details on distribution scope or associated adverse events.
The FDA has classified a recall of Baxter Healthcare's Vasopressin in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100 mL single-dose containers, as a Class II recall. The recall, identified by NDC 0338-9647-12, was initiated due to current good manufacturing practice (CGMP) deviations, according to the source.
The FDA has issued a Class II recall for Baxter Healthcare Corporation's Vasopressin in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), supplied in 100 mL single-dose containers under NDC 0338-9640-12. The recall notice cites cGMP deviations as the reason for the action. No additional clinical details were provided in the source notice.
Accord Healthcare, Inc. issued a Class II recall of Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), in 1000-count bottles, NDC 16729-452-17. The product was manufactured by Intas Pharmaceuticals Limited in India and distributed for Accord Healthcare in Raleigh, NC. The recall reason cited is that the drug is subpotent.
Accord Healthcare, Inc. has initiated a Class II recall of Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), supplied in 1000-count bottles under NDC 16729-450-17. The product, manufactured by Intas Pharmaceuticals Limited in India, was recalled due to being subpotent, according to the recall notice.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), sold in 90-count and 1000-count bottles (NDC 16729-451-15 and 16729-451-17). The product was manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare. The recall reason cited is that the drug is subpotent.
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), distributed in 90-count (NDC 16729-456-15) and 1000-count (NDC 16729-456-17) bottles, manufactured by Intas Pharmaceuticals Limited in India, according to the recall notice. The recall was classified as Class II due to the product being subpotent, per the notice. The notice did not specify additional clinical details or reported adverse events.
The FDA has classified a Class II recall of Accord Healthcare's Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, NDC 16729-455-17, manufactured by Intas Pharmaceuticals Limited in India. The recall reason listed is that the product is subpotent. Class II recalls involve situations where use of the product may cause temporary or medically reversible adverse health consequences.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, NDC 16729-458-15, manufactured by Intas Pharmaceuticals Limited in India. The recall reason listed is subpotent drug. The product is Rx only and was manufactured for Accord Healthcare, Inc. of Raleigh, NC.
