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

Dr.Reddys Laboratories (DRL) has initiated recall of one lot of Allopurinol Tablets, USP 300mg in US for presence of foreign substance. The recall followed complaint with a customer observing embedded object in tablet. Investigations indicated it could be fragments of nitrile glove used in production area. The risk to patients due to the contamination in the tablet would be minimal, except for rare possibility of ingestion of the very small particles along with tablet and impact on the GI tract. Allupurinol is indicated for decreasing high blood uric acid levels, and treatment of gout.

cGMP practices for preventing contamination

Nitrile gloves, latex gloves etc are used in Pharma clean rooms by personnel during manufacture, to avoid human touch and direct contact with the product. There is possibility of gloves getting torn, damaged while wearing, during handling of equipment, bulk containers, bulk transfer of materials, inspection, cleaning etc .This should be promptly identified and assessed for contamination risk. It will be a good cGMP practice to control issuance of consumables and accessories like gloves and monitor their usage. For e.g., at end of each shift reconcile the number of pairs of gloves issued and used, number of pairs damaged. Investigate any discrepancy, observation of any wear and tear and assess possibility of fragments and particulates to contaminate the product. If there is risk of contamination, isolate and segregate the material and product for detailed inspection. This helps in proactively identifying issues and taking actions to limit the impact and prevent recalls

References:

• USFDA Enforecement Report DRL Allopurinol
• Notice of Recall