Recalls and safety alerts from the FDA, newest first.
Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.
Khong Guan Corporation is recalling specific lots of “Glutinous Rice Balls with Black Sesame Filling” because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reactions if they consume these products
Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators due to a potential breach of sterility in the packaging process.
The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.
Bristol Laboratories Limited is recalling one batch (7124002) of Phenoxymethylpenicillin 250 mg/5 ml Oral Solution Sugar Free due to product labelling issues.
Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 1,800 units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 10,500 units
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). — Cipla USA, Inc. · Class II · Ongoing · 31,824 bottles
Lack of Assurance of Sterility — Asclemed USA Inc. · Class II · Ongoing · N/A
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 100 units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 18,000 units
Presence of Foreign Substance — Lupin Pharmaceuticals Inc. · Class II · Ongoing · 2,530,182 bottles
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 125 units
Subpotent Drug — ACCORD HEALTHCARE, INC. · Class II · Ongoing · 6432 bottles
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · N/A
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). — Cipla USA, Inc. · Class II · Ongoing · N/A
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). — Cipla USA, Inc. · Class II · Ongoing · N/A
Lack of Assurance of Sterility — Asclemed USA Inc. · Class II · Ongoing · N/A
Lack of assurance of Sterility: — ACCORD BIOPHARMA INC · Class II · Ongoing · 326 vials
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 7,650 units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel — CareFusion 213, LLC · Class II · Ongoing · 1,200 units
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. — Lupin Pharmaceuticals Inc. · Not Yet Classified · Ongoing · 64,894 units