Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Loss of Potency: Accord / Intas Recall Hypothyroidism / Thyroxine Drug

Jul 25, 2025

Concerns of Beta-lactam Contamination Triggers Massive Recall by Glenmark

Apr 28, 2025

Chattem Inc Recall Antihistamine Sleeping Aid Drug Due to NDSRI Impurity

Apr 15, 2025

NDSRIs: Glenmark Recalls Several Lots of Cardiovascular Drug

Feb 06, 2025

Growing Trend of Drug Recalls for NDSRIs

Dec 21, 2024

API Key SM Source Concerns: Lupin Recall 600000 Bottles of Hypertension Medication

Dec 05, 2024

Nitrosocinacalcet Nitrosamine Impurity Triggers Big Recall From Dr.Reddys, Accord

Nov 05, 2024

Dr.Reddy’s Recall Allopurinol Tablets Due to Fragments From Nitrile Gloves!!!

Jul 08, 2024

Sagent recalls Docetaxel Injection for particulate matter

May 31, 2024

Beta Lactam Contamination: Scynexis Recall Brexafemme Tablets

Oct 09, 2023

Recall / Event ID: 91441/ Recall Number: D-0162-2023 / Macleods/ 5 Jan 2023 / Class III

Apr 18, 2023

Recall / Accord Healthcare /Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial – Lot # R2200232 due to Product Mix-Up / 23 Dec 2022

Apr 18, 2023

Strides recall Prednisolone tablets for mix up

Apr 17, 2023

Recall / Event ID: 82288/ Recall Number: D-0992-2019/ Apotex Inc/ 1 March, 2019 / Class II

Apr 09, 2023