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Dexmedetomidine HCl (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

Glycopyrrolate (Denver Solutions) – Leaking Syringes (2025)

Lack of Assurance of Sterility: Leaking/damaged syringes.

Class IIModerate

FDAMar 31, 2025Nationwide• Denver Solutions, LLC DBA Leiters Health

NFH Iron Dietary Supplements (NFH) – Poisoning Risk (2025)

This recall involves NFH Dietary Supplement bottles for Iron SAP, Heme Iron SAP and Prenatal SAP. The bottles are white with the brand name "NFH" and the firm's logo of a leaf in blue. The date code is on the bottom of the bottle. The recalled dietary supplement bottles have the following description and come in various sizes: Product Name Description Sizes Date Codes Iron SAP Iron Glycinate 60 Capsules (1029U) 120 Capsules (1167U) 60 capsules 5398705/31/2027 5398805/31/2027 5398512/31/2026 5398612/31/2026 5398306/30/2026 5398406/30/2026 N00274 07/31/2025 120 capsules 538975/31/2027 539875/31/2027 539885/31/2027 5398512/31/2026 5398612/31/2026 539846/30/2026 N00274 6/30/2025 Heme Iron SAP (Porcine) Superior Absorption and Bioavailability 60 Capsules (1124U) N00265 - 03/31/2025 53809 - 05/31/2026 53810 - 07/31/2026 57807 - 10/30/2026 53811 - 10/31/2026 57806 - 10/31/2026 62379 - 08/31/2027 Prenatal SAP Multivitamin 180 Capsules (1034U) 5821709/30/2027 5822009/30/2027 5736105/31/2027 5736905/31/2027 5737005/31/2027 5737205/31/2027 5821405/31/2027 5396803/31/2027 5719401/31/2027 5736001/31/2027 5396311/30/2026 5396411/30/2026 5396511/30/2026 5396611/30/2026 5396711/30/2026 5395410/31/2026 5395610/31/2026 5395810/31/2026 5396010/31/2026 5396110/31/2026 5396210/31/2026 5395307/31/2026 5394605/31/2026 5394504/30/2026 N00287 08/31/2025 N00285 04/30/2025 N00284 03/31/2025

CPSCMar 27, 2025Nationwide• Nutritional Fundamentals for Health (dba NFH), of Canada

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Class IIModerate

FDAMar 26, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Unisom SleepMinis (Chattem) – Nitrosamine Impurity (2025)

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

Class IIModerate

FDAMar 26, 2025Nationwide• Chattem Inc