Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Internal Medicine 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) due to the presence of particulate matter identified as stainless steel particles in the solution. The recall notice does not provide further details on the scope of distribution or associated adverse events.
The FDA has classified 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), 100 mL single-dose containers, NDC 0338-9640-12. The recall was initiated due to current good manufacturing practice (CGMP) deviations, as stated in the FDA recall notice.
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, packaged 24 units per case. The recall notice states the reason is presence of particulate matter, identified as fiberglass, within the affected product.
Baxter Healthcare Corporation has issued a Class II recall for Nexterone (amiodarone HCl), 360 mg/200 mL (1.8 mg/mL), supplied in GALAXY Single-Dose Containers under NDC 43066-360-20. The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, as reported in the recall notice.
Baxter Healthcare Corporation issued a Class II recall for Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), supplied in GALAXY Single-Dose Containers under NDC 0338-3552-48. The recall was initiated due to CGMP deviations, according to the source notice.
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 notice cites current good manufacturing practice (CGMP) deviations as the reason for the action. No additional clinical details were provided in the source notice.
Baxter Healthcare Corporation has issued a Class II recall for 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. According to the recall notice, the action was initiated due to CGMP deviations. The source did not specify the exact nature of the deviation or additional distribution details.
The FDA has issued a Class II recall for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, NDC 16729-449-17. The product was manufactured for Accord Healthcare by Intas Pharmaceuticals in India and is being recalled due to being a subpotent drug, according to the recall notice.
A Class II recall has been issued for Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles (NDC 16729-458-15), manufactured for Accord Healthcare, Inc. by Intas Pharmaceuticals Limited. The recall was initiated due to the product 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), packaged in 90-count and 1000-count bottles (NDC 16729-451-15 and 16729-451-17). The product, manufactured by Intas Pharmaceuticals Limited in India, was recalled due to subpotency, according to the recall notice.
Accord Healthcare, Inc. issued a Class II recall of Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in 90-count bottles (NDC 16729-456-15) and 1000-count bottles (NDC 16729-456-17), manufactured by Intas Pharmaceuticals Limited in India. The recall notice cites the product as subpotent. No additional details on distribution scope or patient impact were provided in the source.
A Class II recall has been issued for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), in 1000-count bottles, NDC 16729-455-17, manufactured by Intas Pharmaceuticals in India. The recall notice cites the product as a subpotent drug. The affected product is labeled Rx Only and was manufactured for Accord Healthcare, Inc. of Raleigh, NC.
Fresenius Kabi USA, LLC has issued a Class I recall for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, NDC 65219-594-20. According to the recall notice, an internal investigation at the firm found the product to contain glass particles. The recall pertains to this Rx Only product manufactured by Fresenius Kabi USA, LLC in Lake Zurich, Illinois.
