Lupin Limited recalls Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltim
Recalled September 14, 2016 · FDA recall D-1493-2016 · Lupin
Hazard
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. · FDA Class III
Units
11,812 bottles
Sold at
US No recalled product was distributed to any foreign consignees by Lupin.
Description
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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
Manufacturer(s)
Lupin Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →