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Research, guidelines, and safety alerts for your specialty.
Recent updates in Neurology from the last 30 days.
A Class I recall has been issued for Baxter Healthcare Corporation's Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06), manufactured in the USA. The recall notice states that particulate matter identified as stainless steel particles was found in the solution. Class I recalls are designated for situations where use of the product could cause serious injury or death.
Baxter Healthcare Corporation has issued a Class II recall for Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL, supplied in GALAXY 50 mL single-dose containers (NDC 0338-3612-50). The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, as stated in the recall notice.
The FDA has classified as Class II a recall by Baxter Healthcare Corporation of 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 notice cites current Good Manufacturing Practice (CGMP) deviations as the reason for the action, without providing further clinical detail in the source text.
Baxter Healthcare Corporation has issued a Class I recall for 500 mL VIAFLEX bags of 0.9% Sodium Chloride Injection USP, NDC 0338-0049-03, packaged 24 units per case. The recall notice states the reason is the presence of particulate matter identified as fiberglass in the product.
The FDA has classified a recall of Baxter Healthcare's CARDENE IV (nicardipine hydrochloride) 40 mg in 0.83% sodium chloride injection, supplied in 200 mL GALAXY single-dose containers, as a Class II recall. The source states the recall is due to cGMP (current good manufacturing practice) deviations, without further detail on the specific defect.
The FDA issued a Class II recall for Baxter Healthcare's Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL, supplied in GALAXY Single-Dose Containers under NDC 0338-3583-01. The recall was initiated due to current good manufacturing practice (CGMP) deviations, as stated in the recall notice.
The FDA classified a recall of Baxter Healthcare's Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection (400 mcg per 100 mL) as a Class II action. The recall notice cites current good manufacturing practice (CGMP) deviations as the reason for the action, affecting product supplied in Galaxy 100 mL single dose containers under NDC 0338-9557-12.
Accord Healthcare, Inc. has issued a Class II recall for Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), sold in 90-count bottles under NDC 16729-458-15. The product, manufactured by Intas Pharmaceuticals Limited in India, was recalled due to being classified as a subpotent drug.
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), supplied in 90-count and 1000-count bottles, in a Class II recall. The FDA classification indicates the reason for recall is that the drug is subpotent. The product was manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare.
The FDA has classified a recall of Accord Healthcare's Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, NDC 16729-448-17, as a Class II recall. The reason listed for the recall is that the product is subpotent. The tablets were manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc.
A Class II recall has been issued by Accord Healthcare, Inc. for Levothyroxine Sodium Tablets, USP, 25 mcg, 1000-count bottles (NDC 16729-447-17), manufactured by Intas Pharmaceuticals Limited. The recall notice cites the product as a subpotent drug.
Apotex Corp. issued a Class II recall for Paxil CR (paroxetine extended-release tablets), 37.5mg, 30-count bottles, NDC 60505-4379-3. According to the FDA recall notice, the product failed to meet 24-month stability testing acceptance criteria due to failed dissolution specifications.
Fresenius Kabi USA issued a Class I recall for Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, NDC 65219-594-20. The company states an internal investigation found the product contained glass particles. FDA classifies this as a Class I recall, indicating the most serious type.
