The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 recall covering all strengths and all batches of Xeal Pharma’s clopidogrel oral solutions and suspensions manufactured before the recall notification. A formulation error resulted in the affected products containing 76% of the required amount of active ingredient. The case highlights three critical quality challenges: control of active substance content in liquid dosage forms, investigation of out-of-specification (OOS) results, and scientifically justified assessment of the full batch impact. 1. The recall: what is established In its notice of...