Amlodipine Besylate Tablets USP recalled over manufacturing violations

Recall date

February 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Lupin Limited recalls Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltim…

Recall number

D-1492-2016

FDA classification

Class III

Brand / firm

Lupin Limited

Sold / distributed

US No recalled product was distributed to any foreign consignees by Lupin.

Why it was recalled

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09