The latest headlines across every section, pulled from official and open-access sources.
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
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 · 400 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 · 146,600 units
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. — Lannett Company Inc. · Class II · Ongoing · 1392 bottles
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product. — Boehringer Ingelheim Pharmaceuticals, Inc. · Class II · Ongoing · 560 bottles
Reduced or no recovery of some strains of Neisseria gonorrhoeae. — Remel, Inc · Class II · Ongoing · 1573
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. — Medline Industries, LP · Class II · Ongoing · 9,272 kits
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change. — RAYSEARCH LABORATORIES AB · Class II · Ongoing · 3 units
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. — Bard Access Systems, Inc. · Class II · Ongoing · 3,240
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. — Medline Industries, LP · Class II · Ongoing · 9,272 kits
Potential sterile breach of the pouches in which devices are packaged. — Boston Scientific Corporation · Class II · Ongoing · 81,543 units
Due to out-of-specification, or potential out-of-specification, levels of endotoxins — TELEFLEX LLC · Class II · Ongoing · 1488700
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. — Medline Industries, LP · Class II · Ongoing · 15662 kits