FDA-Drug2016-09-14Class III
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
Lupin Limited
Hazard
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Sold states
US No recalled product was distributed to any foreign consignees by Lupin.
Affected count
43,536 bottles
Manufactured in
15-B, Phase 1A, Verna Industrial Area, Verna, Salcette, Goa, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1492-2016Don't want to check this manually?
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