FDA recall D-1493-2016

Product

Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2016-02-19

Report date

2016-09-14

Termination date

2017-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Verna, Salcette, Goa, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1493-2016