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Research, guidelines, and safety alerts for your specialty.
Recent updates in Gynecology & Obstetrics from the last 30 days.
Baxter Healthcare Corporation has issued a Class II recall for Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), supplied in 50 mL single-dose GALAXY containers under NDC 0338-9549-50. The recall notice cites CGMP deviations as the reason for the action.
Baxter Healthcare Corporation has issued a Class II recall for Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL, supplied in GALAXY Single-Dose Containers under NDC 0338-3552-48. The recall notice cites current Good Manufacturing Practice (CGMP) deviations as the reason for the action.
Baxter Healthcare Corporation has issued a Class II recall for Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), supplied in GALAXY 50 mL single dose containers (NDC 43066-995-24). The recall was initiated due to current good manufacturing practice (CGMP) deviations, as reported in the recall notice. No additional details on the specific deviation or clinical impact were provided in the source text.
Optimal Balance Pharmacy issued a Class I recall for its Glutathione 200 mg/mL sterile multidose injection vials, citing out-of-specification bacterial endotoxin test results indicating microbial contamination of the sterile product. The recall covers the IM/IV injectable formulation, which also contains ascorbic acid and benzyl alcohol, manufactured at the Houston, TX facility.
The FDA recall notice covers Baxter Healthcare's 0.9% Sodium Chloride Injection USP 500 mL in VIAFLEX plastic containers, NDC 0338-0049-03, packaged 24 units per case. The notice states the recall was issued due to the presence of particulate matter identified as fiberglass. This is classified as a Class I recall, the FDA's most serious recall category.
Fresenius Kabi USA has issued a Class I recall of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL, 20 mL vials (NDC 65219-594-20), according to the recall notice. The firm's internal investigation found the product to contain glass particulate matter, per the source.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), distributed in 90-count and 1000-count bottles (NDC 16729-454-15 and 16729-454-17). The recall notice states the reason for recall is that the product is subpotent. The tablets were manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc. of Raleigh, NC.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), supplied in 1000-count bottles under NDC 16729-447-17. The recall notice states the reason for action is that the product is subpotent. The tablets were manufactured by Intas Pharmaceuticals Limited for Accord Healthcare, Inc.
Accord Healthcare has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 125 mcg, in 1000-count bottles (NDC 16729-453-17), manufactured by Intas Pharmaceuticals Limited. The recall reason listed is that the product is subpotent.
Accord Healthcare, Inc. issued a Class II recall for Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, NDC 16729-448-17, manufactured by Intas Pharmaceuticals Limited. The recall was initiated due to the product being subpotent, according to the recall notice.
The FDA recall notice reports a Class II recall of Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), manufactured for Accord Healthcare, Inc. and produced by Intas Pharmaceuticals Limited, affecting 90-count (NDC 16729-457-15) and 1000-count (NDC 16729-457-17) bottles. The notice states the reason for recall is that the product is subpotent.
