Duloxetine Delayed-Release Capsules, USP, 30mg recall — FDA D-0568-2024
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Complete FDA and NHTSA recall records dated in July 2024.
These records include useful source details for the selected month.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
Honda (America Honda Motor Co.) is recalling certain 2024 CR-V vehicles. The tire identification number (TIN) is missing the four-digit date code. As such, these vehicles fail to comply…
Nissan North America, Inc. (Nissan) is recalling certain 2024 Nissan Sentra vehicles. The windshield may have air bubbles on the front lower driver's side, which can obscure the Vehicle…
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.