Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Pediatric Emergency Medicine 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) due to the presence of particulate matter identified as stainless steel particles in the solution. The recall notice does not specify additional details on distribution or affected lot numbers beyond the product identifier listed.
The FDA recall notice reports a Class II recall of Baxter Healthcare's Nexterone (amiodarone HCl) 360 mg/200 mL (1.8 mg/mL) GALAXY Single-Dose Container solution, NDC 43066-360-20. The notice attributes the recall to current good manufacturing practice (CGMP) deviations.
FDA has classified a recall of Baxter Healthcare's Vancomycin Injection, USP in 5% Dextrose (1 g per 200mL, 5 mg/mL) in GALAXY Single-Dose Containers as Class II. The recall, listed under NDC 0338-3552-48, is attributed to current good manufacturing practice (CGMP) deviations, according to the FDA recall notice.
FDA issued a Class I recall for Optimal Balance Pharmacy's Glutathione 200 mg/mL sterile multidose injection vials, intended for IM or IV use. The recall was initiated after out-of-specification results were obtained for bacterial endotoxin, indicating microbial contamination of the sterile product.
Baxter Healthcare Corporation has issued a Class I recall for 0.9% Sodium Chloride Injection USP, 500 mL, in VIAFLEX plastic containers (24 units per case, NDC 0338-0049-03). The recall was initiated due to the presence of particulate matter identified as fiberglass in the product.
FDA has classified as Class II a recall by Baxter Healthcare Corporation of Vancomycin Injection, USP, in 0.9% Sodium Chloride (1g per 200 mL, 5 mg/mL) supplied in GALAXY Single-Dose Containers, NDC 0338-3583-01. The recall notice cites current good manufacturing practice (cGMP) deviations as the reason for the action. No further details on the specific nature of the deviation or associated clinical risk are provided in the source text.
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 in 100 mL single-dose containers under NDC 0338-9647-12. The recall was initiated due to current good manufacturing practice (CGMP) deviations, as reported in the recall notice.
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), in 90-count (NDC 16729-454-15) and 1000-count (NDC 16729-454-17) bottles, manufactured by Intas Pharmaceuticals Limited in India. The recall, classified as Class II, was issued due to the drug being subpotent.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), supplied in 1000-count bottles, Rx Only, NDC 16729-453-17. The recall notice cites the reason as subpotent drug, with the product manufactured by Intas Pharmaceuticals Limited in India for distribution by Accord Healthcare in Raleigh, NC.
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 was initiated due to the presence of particulate matter, identified as glass and stopper pieces, in the product.
FDA has classified a recall of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), manufactured by Fresenius Kabi USA, as a Class I recall. According to the recall notice, an internal investigation at the firm found the product to contain glass particulate matter. The affected product is identified by NDC 65219-594-20.
