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Research, guidelines, and safety alerts for your specialty.
Recent updates in Neonatology from the last 30 days.
Baxter Healthcare Corporation has issued a recall for its Dextrose Injection, USP, 70%, 2000 mL bags (NDC 00338-0719-06) after identifying stainless steel particulate matter in the solution. The recall is classified as Class I, the FDA's designation for situations where use of the affected product could cause serious adverse health consequences or death.
The FDA reports a Class I recall of Optimal Balance Pharmacy's compounded Glutathione 200 mg/mL, 30 mL sterile multidose vials, intended for IM or IV injection. The recall was issued after out-of-specification results for bacterial endotoxin were obtained, indicating microbial contamination of the sterile product. The product was manufactured by Optimal Balance Pharmacy, located in Houston, TX.
The FDA classified this as a Class I recall of Baxter Healthcare'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 action was initiated due to the presence of particulate matter identified as fiberglass in the product.
Baxter Healthcare Corporation has issued a Class II recall for Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), packaged in GALAXY Single-Dose Containers (NDC 0338-3552-48). The recall notice cites current good manufacturing practice (CGMP) deviations as the reason for the action.
FDA has classified a Class II recall for Baxter Healthcare's Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL, supplied in a GALAXY single dose container (NDC 0338-3814-50). 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 Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL, supplied in Galaxy 100 mL Single Dose Containers (NDC 0338-9557-12). The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations, as reported in the FDA enforcement notice.
The FDA has classified a recall of Baxter Healthcare'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 notice cites current Good Manufacturing Practice (CGMP) deviations as the reason, affecting product under NDC 0338-3583-01.
The FDA-classified Class II recall notice reports that Mallinckrodt Hospital Products Inc. recalled 5 mL multiple-dose vials of Acthar Gel (repository corticotropin injection), NDC 63004-8710-1 and 63004-8710-2, due to the presence of particulate matter identified as glass and stopper pieces. The notice does not specify additional clinical outcomes or corrective actions beyond identifying the affected lots and product defect.
Accord Healthcare, Inc. is recalling Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), in 90-count and 1000-count bottles, classified as a Class II recall due to the drug being subpotent. The tablets were manufactured by Intas Pharmaceuticals Limited in India for Accord Healthcare, Inc.
FDA has classified a Class II recall of Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), manufactured for Accord Healthcare, Inc. and produced by Intas Pharmaceuticals Limited, distributed in 90-count (NDC 16729-456-15) and 1000-count (NDC 16729-456-17) bottles. The recall reason listed is that the product is subpotent.
The FDA reports a Class II recall of Accord Healthcare's Levothyroxine Sodium Tablets, USP, 150 mcg (1000-count bottles, NDC 16729-455-17), manufactured by Intas Pharmaceuticals. The recall reason listed is that the product is subpotent.
The FDA has classified a Class II recall for Accord Healthcare's Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), supplied in 1000-count bottles under NDC 16729-449-17. The recall notice cites the reason as a subpotent drug, meaning the tablets contain less active ingredient than labeled. The product was manufactured for Accord Healthcare, Inc. by Intas Pharmaceuticals Limited in India.
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 FDA classification cites the product as subpotent, meaning the tablets contain less active drug than labeled.
