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Research, guidelines, and safety alerts for your specialty.
Recent updates in Cardiology from the last 30 days.
Baxter Healthcare Corporation has issued a Class I recall for Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06). The recall was initiated due to the presence of particulate matter identified as stainless steel particles found in the solution.
Mylan Pharmaceuticals Inc. issued a Class II recall for Prasugrel Tablets, USP, 10mg, 30-count bottles, NDC 0378-5186-93. The recall was initiated because the product failed dissolution specifications, not meeting 18-month stability testing acceptance criteria.
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, 24 units per case), citing the presence of particulate matter identified as fiberglass. The recall notice does not specify additional details on distribution scope or clinical outcomes.
Baxter Healthcare Corporation has issued a Class II recall of Nexterone (amiodarone HCl), 360 mg/200 mL (1.8 mg/mL), supplied in GALAXY Single-Dose Containers, NDC 43066-360-20. The recall was initiated due to current good manufacturing practice (CGMP) deviations, according to the recall notice. The product is a sterile, nonpyrogenic, iso-osmotic solution in dextrose manufactured in the USA.
The FDA has classified as a Class II recall Baxter Healthcare Corporation's Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100 mL Single-Dose Container (NDC 0338-9640-12). The recall notice cites cGMP deviations as the reason for the action. No further details on the specific deviation or clinical impact were provided in the source text.
FDA has classified a recall by Baxter Healthcare Corporation as Class II, affecting 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, as reported by FDA.
The FDA has classified a Class II recall of Baxter Healthcare's Cardene IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL, supplied in GALAXY Single-Dose Containers under NDC 43066-016-10. According to the recall notice, the action was initiated due to current good manufacturing practice (CGMP) deviations. The notice does not specify the nature of the deviations or additional details beyond the product identification and recall classification.
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, manufactured by Intas Pharmaceuticals Limited. The recall reason cited is that the product is subpotent.
FDA has classified a Class II recall for Accord Healthcare, Inc.'s Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, NDC 16729-450-17, manufactured by Intas Pharmaceuticals Limited. The recall reason listed is subpotent drug.
The FDA classified a Class II recall for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), distributed in 90-count and 1000-count bottles. The recall notice states the reason is a subpotent drug, with the product manufactured by Intas Pharmaceuticals Limited in India and marketed by Accord Healthcare, Inc. of Raleigh, NC.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), supplied in 1000-count bottles under NDC 16729-455-17. The FDA recall notice states the reason for recall is that the product is subpotent. The tablets were manufactured by Intas Pharmaceuticals Limited for Accord Healthcare, Inc.
Fresenius Kabi USA has issued a Class I recall of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL) in 20 mL vials, NDC 65219-594-20. According to the recall notice, an internal investigation at the firm found the product to contain glass particulate matter. The FDA classifies this as a Class I recall, the most serious category, indicating use of the affected product could cause serious injury or death.
Hikma Pharmaceuticals USA (via Exelan Pharmaceuticals) issued a Class II recall of Ramipril Capsules USP, 10 mg, in 100-capsule (NDC 76282-673-01) and 500-capsule (NDC 76282-673-05) bottles. According to the recall notice, the action was prompted by an out-of-specification result for the process impurity dicyclohexylurea (DCU) found during impurities and degradation testing. The product was manufactured by West-Ward Columbus Inc. for Exelan Pharmaceuticals.
