Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Public Health from the last 30 days.
Baxter Healthcare Corporation issued a Class I recall for Dextrose Injection, USP, 70%, in 2000 mL bags (NDC 00338-0719-06) after identifying particulate matter in the solution, described as stainless steel particles. The FDA classification indicates the agency considers this a situation in which use of the product could cause serious adverse health consequences or death.
Optimal Balance Pharmacy is recalling Glutathione 200 mg/mL, 30 mL sterile multidose vials labeled for IM or IV injection use only, according to the recall notice. The action was initiated due to microbial contamination of the sterile product, with out-of-specification results obtained for bacterial endotoxin, the notice states. The FDA has classified this as a Class I recall.
The FDA has classified a recall of Baxter Healthcare Corporation's Vancomycin Injection, USP, in 0.9% Sodium Chloride (1g per 200 mL, 5 mg/mL) in GALAXY Single-Dose Containers as a Class II recall. The stated reason for the recall is current Good Manufacturing Practice (CGMP) deviations. The affected product is identified by NDC 0338-3583-01.
FDA classified this as a Class II recall of Baxter Healthcare's Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL, supplied in GALAXY 50 mL single dose containers (NDC 0338-4114-50). The recall was initiated due to current good manufacturing practice (CGMP) deviations, according to the source.
Baxter Healthcare Corporation has issued a Class II recall for Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Containers, NDC 0338-3552-48. The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, as reported in the recall notice.
The FDA recall notice describes a Class II recall of Baxter Healthcare Corporation's Vasopressin in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100 mL single-dose containers, NDC 0338-9647-12. The stated reason for the recall is current good manufacturing practice (CGMP) deviations. No additional details about the specific deviation or clinical impact were provided in the source text.
Baxter Healthcare Corporation issued a Class II recall for Nexterone (amiodarone HCl) 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Containers, NDC 43066-360-20, due to current Good Manufacturing Practice (CGMP) deviations. The product is a sterile, nonpyrogenic, iso-osmotic solution in dextrose used as a premixed intravenous antiarrhythmic. No further clinical details were provided in the source text.
FDA reports a Class I recall by Fresenius Kabi USA, LLC for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, NDC 65219-594-20. The recall was initiated after an internal investigation at the firm found the product to contain glass particles.
The FDA has classified as a Class II recall a batch of Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, NDC 16729-455-17, manufactured by Intas Pharmaceuticals for Accord Healthcare, Inc. The recall reason listed is subpotent drug. The notice does not specify lot numbers, distribution scope, or additional clinical details.
A Class II recall has been issued for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, NDC 16729-449-17, manufactured by Intas Pharmaceuticals Limited in India. The recall reason listed is subpotent drug.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), in 90-count bottles, NDC 16729-458-15, manufactured by Intas Pharmaceuticals Limited. The recall was classified due to the product being subpotent, according to the recall notice.
FDA has classified a Class II recall of Accord Healthcare's Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, NDC 16729-453-17, manufactured by Intas Pharmaceuticals. The recall reason listed is that the drug is subpotent.
FDA has classified as Class II a recall of Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in 90-count and 1000-count bottles, manufactured by Intas Pharmaceuticals for Accord Healthcare, Inc. The recall was issued due to the product being subpotent, according to the FDA notice.
