Group items tagged

Pharmaceutical recalls are complicated and expensive, just like in any other business. Pharmaceutical recalls, however, pose a further risk because they might change both short- and long-term health effects. To ensure smooth recalls with few negative effects on public health, it is crucial to understand the pharmaceutical product recall procedure and the roles of each key player. Throughout the recall procedure, patient safety is crucially ensured by the FDA, pharmaceutical companies, pharmacy technicians, and other healthcare professionals. Learning about pharma recalls, procedures, and responsibilities is essential for guaranteeing patient safety for key actors like the Food and Drug Administration (FDA), manufacturers, and other medical specialists. RECALL CLASSIFICATIONS Recalls can fall into one of three categories-class I, II, or III-with class I being the most serious and lethal. Products that have the potential to result in serious, permanent complications or death are subject to Class I recalls. Class II recalls are recommended for product flaws that have a low likelihood of harmful events or that can result in reversible side effects. Last but not least, class III recalls typically arise from problems with packaging that do not pose a risk. Since they are frequently issued out of an abundance of prudence rather than due to any negative impacts, many people may even describe this kind of recall as benign.

PCCA Limited has issued a recall for its Ketamine 50mg/5ml and 100mg/5ml oral solutions after a small number of bottles have been observed to contain crystalline material. The company said it is recalling impacted batches from patients, pharmacies and hospitals as a precautionary measure. "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers and the company has traceability of the onward distribution by their customers to patients directly," the MHRA said in an alert. Check the website.

Pfizer has recalled all stocks of Accupro - including 5mg, 10mg, 20mg, 40mg film-coated tablets - as a precautionary measure due to the identification of a nitrosamine above the acceptable limit. "Following testing, N-nitroso-quinapril, has been observed at a level above the acceptable limit. Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. The recall is at pharmacy and wholesaler level," the Pharmaceutical Services Negotiating Committees (PSNC) reported. The Department of Health and Social Care (DHSC) said: "All strengths of quinapril (Accupro) tablets have been recalled with a resupply date to be confirmed. Pfizer are the sole supplier of quinapril tablets in the UK. Alternative ACE inhibitors remain available and can support an uplift in demand."

The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled Labetalol 200mg tablets (Tillomed Laboratories Ltd) directed to pharmacies and wholesalers. Manufacturer, Tillomed Laboratories is recalling one batch of Labetalol 200mg tablets due to an error on the foil blister packaging. The incorrect aluminium foil blister packaging states Labetalol 100mg tablets, however it should be labelled as Labetalol 200mg Tablets. This error has occurred at the primary packing operation. Tillomed Laboratories Limited has confirmed the actual tablet contained in the blister is Labetalol 200mg Tablets, which is the strength stated on the outer carton. This error is limited to the packaging of the batch with 100mg aluminium foil blister and does not impact the lot (batch) number or expiry as printed on the outer carton and aluminium foil blister. Healthcare professionals has been advised to stop supplying the batches immediately. Quarantine all remaining stock and return it to supplier using supplier's approved process.