Natco Pharma recalls Lansoprazole Capsules for cGMP deviations

Natco Pharma is recalling one more lot of Lanzoprazole 15 mg delayed release capsules for cGMP deviations in March 2024. The drug is distributed by Rising Pharma Holdings. Lanzoprazole is indicated for treatment of frequent heartburn.

The Lanzoprazole capsules are manufactured by Natco Pharma unit at Kothur, India, Earlier in February 2024 Natco had recalled one lot of Lanzoprazole capsules for bottle sealing issues and observation of capsules sticking together, active spheres sticking to capsules, capsules with holes and exposed drug, bubbles & blemishes. This recall was triggered from a customer complaint and one lot of Lanzoprazole capsules (#411987) was recalled. As part of impact assessment of the complaint, defective capsules were noticed for lot# 411988 as well and recall has been initiated for the same (as per recall notification update by the Board of Pharmacy, California),

Natco Pharma Kothur facility was inspected by USFDA in October 2023, with eight observations. The major observations in the USFDA 483 included lapses in cleaning procedures, data integrity issues with torn cGMP documents in scrap yard and deficiencies in OOS investigations.

FDA Enforcement report