Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle recall — FDA D-0675-2026
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
Lack of Assurance of Sterility
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Elevated coliforms
Potential contamination with plastic material
Product may be contaminated with Clostridium botulinum.
undeclared colors (yellow#5)
Dietary supplement product Ocular Plus contains undeclared Yellow#5.
Dietary supplement product Vista MAX contains undeclared Yellow#5.
Undeclared peanuts.
Product may be contaminated with Salmonella Typhimurium
Browse recent months with enough recall history for useful comparison.