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Research, guidelines, and safety alerts for your specialty.
Recent updates in Family Medicine from the last 30 days.
Baxter Healthcare Corporation issued a Class I recall for Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06). The recall states the product contains particulate matter identified as stainless steel particles in the solution.
Mylan Pharmaceuticals Inc. is recalling Prasugrel Tablets, USP, 10mg (30-count bottles, NDC 0378-5186-93), classified as a Class II recall. The manufacturer reported that the product failed dissolution specifications and did not meet 18-month stability testing acceptance criteria.
Teva Pharmaceuticals USA has issued a Class II recall for traZODone Hydrochloride Tablets, USP, 50 mg (100-count bottles, NDC 50111-560-01), manufactured in Croatia by Pliva Hrvatska for Teva. The recall was initiated due to the presence of foreign tablets or capsules within the product packaging.
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. The recall states the product may contain particulate matter identified as fiberglass. FDA classifies this as a Class I recall, indicating the most serious recall category.
Baxter Healthcare Corporation has issued a Class II recall for Vasopressin in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), supplied as a 100 mL single-dose container (NDC 0338-9647-12). The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations, according to the recall notice.
FDA has classified a Class II recall of Baxter Healthcare Corporation's Famotidine Injection in Sodium Chloride Injection, 20 mg per 50 mL, supplied in GALAXY Single Dose Containers (NDC 0338-5197-41). The recall notice cites current good manufacturing practice (CGMP) deviations as the reason for the action; no further details on the specific defect or clinical impact are provided in the source.
Baxter Healthcare Corporation has issued a Class II recall for Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL), packaged in GALAXY 50 mL Single Dose Containers under NDC 0338-3814-50. The recall notice cites current Good Manufacturing Practice (CGMP) deviations as the reason for the action. No further clinical details were provided in the source notice.
The FDA has classified as Class II a recall by Accord Healthcare, Inc. of Levothyroxine Sodium Tablets, USP, 175 mcg, distributed in 90-count and 1000-count bottles under specified NDC numbers. The recall reason listed is that the product is subpotent.
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, NDC 16729-455-17, manufactured by Intas Pharmaceuticals Limited. The recall is classified as Class II and the reason given is that the product is subpotent.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), supplied in 1000-count bottles under NDC 16729-449-17. The FDA recall notice cites the reason as subpotent drug; the product was manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare.
FDA has classified a Class II recall for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, NDC 16729-458-15, manufactured by Intas Pharmaceuticals. The recall reason listed is that the product is subpotent.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), in 1000-count bottles (NDC 16729-447-17), manufactured by Intas Pharmaceuticals Limited. The recall reason listed is that the product is subpotent.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, NDC 16729-448-17. The tablets were manufactured by Intas Pharmaceuticals Limited in India and distributed by Accord Healthcare. The stated reason for the recall is that the product is subpotent.
