Your medical briefing
Research, guidelines, and safety alerts for your specialty.
Recent updates in Clinical Pharmacology from the last 30 days.
A Class I recall has been issued for Baxter Healthcare's Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06), manufactured in the USA. The recall was initiated after particulate matter identified as stainless steel particles was found in the solution.
Baxter Healthcare Corporation has 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 FDA recall notice cites current good manufacturing practice (CGMP) deviations as the reason for the action.
The FDA recall notice reports a Class II recall by Baxter Healthcare Corporation 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 notice attributes the recall to current good manufacturing practice (CGMP) deviations.
FDA designated a Class I recall for Optimal Balance Pharmacy's Glutathione 200 mg/mL, 30 mL sterile multidose vials intended for IM or IV injection. The recall states the product failed specifications for bacterial endotoxin, indicating microbial contamination of the sterile product. The vials also contain ascorbic acid and benzyl alcohol along with sterile water for injection.
The FDA announced a Class I recall of Baxter Healthcare Corporation's 0.9% Sodium Chloride Injection USP, 500 mL, VIAFLEX plastic containers (NDC 0338-0049-03, 24 units per case). The recall notice states the reason is presence of particulate matter identified as fiberglass. Class I recalls indicate the FDA's most serious designation, used when use of the product could cause serious injury or death.
Baxter Healthcare Corporation has issued a Class II recall of Daptomycin in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), supplied in single-dose 50 mL bags (24 bags per carton, NDC 0338-0714-24). The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, as reported in the recall notice.
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 recall, affecting product under NDC 0338-3583-01, was issued due to current good manufacturing practice (CGMP) deviations, according to the source notice.
FDA has classified a Class II recall for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, NDC 16729-452-17, manufactured by Intas Pharmaceuticals. The stated reason for recall is that the product is subpotent.
Accord Healthcare, Inc. has initiated a Class II recall of Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), supplied in 1000-count Rx Only bottles under NDC 16729-450-17, manufactured by Intas Pharmaceuticals Limited in India. The recall reason listed is that the product is subpotent.
FDA lists 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 Limited. The recall reason stated is subpotent drug.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), supplied in 1000-count bottles under NDC 16729-448-17. The recall reason listed is that the product is subpotent. The tablets were manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, NDC 16729-458-15, manufactured by Intas Pharmaceuticals Limited. The recall reason listed is that the product is subpotent.
FDA reports a Class I recall of Fresenius Kabi's Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL vials, NDC 65219-594-20. The firm's internal investigation found the product contains glass particulate matter. Class I recalls are used by FDA to designate situations in which use of the affected product could cause serious injury or death.
