Chelating Agent Recalled

Lupin Pharmaceuticals Inc. is recalling a single lot of penicillamine tablets. The December 20, 2023, US Food and Drug Administration (FDA) Enforcement Report cited failed dissolution specifications as the reason for the recall.

Affected are penicillamine tablets, 250 mg, in 100-count bottles (NDC 70748-153-01) from lot M200498 (Exp. 6/24). The tablets were manufactured by Lupin Limited, Nagpur, India, for Lupin Pharmaceuticals Inc. Baltimore, Maryland, and were distributed to three wholesale/distributor accounts.

Lupin Pharmaceuticals voluntarily initiated the recall November 22, 2023. On December 13, 2023, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Penicillamine is a prescription chelating agent used for the removal of excess copper in patients with Wilson’s disease and for the reduction of excess cystine excretion in patients with cystinuria. It is also indicated for the treatment of patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.