FDA Warning Letter: Zydus Lifesciences cited for contamination, aseptic processing, and PPQ deficiencies

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What happened FDA inspected Zydus Lifesciences Limited in Gujarat from April 15 to 23, 2024, and cited significant CGMP violations involving investigations, aseptic processing, and process validation. FDA stated that multiple cross-contamination events over about three months were linked to inadequate cleaning of shared equipment. Investigations did not cover all potentially affected batches, equipment, product-contact … Read more

Baxter Recalls One Sodium Citrate Solution Lot for Potential Fiberglass Particulates

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What happened On August 25, 2026, Baxter International announced a voluntary nationwide recall of one lot of Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container, because of potential particulate matter identified as fiberglass. The affected lot is Y493475, product code 2B7867Q, NDC 0338-9669-01, expiring December 31, 2027. It was distributed July 2-11, 2026, … Read more

Baxter Recalls One Lot of 70% Dextrose Injection for Potential Stainless Steel Particles

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What happened On August 25, 2026, Baxter International voluntarily recalled one lot (Y495066) of 70% Dextrose Injection, USP, in 2000 mL VIAFLEX plastic containers because stainless steel particulate matter may be present in the solution. The pharmacy bulk package, not for direct infusion, was distributed from July 25-28, 2026, to healthcare providers and distributors in … Read more