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Class III · Lower riskRecall completed

Amlodipine Besylate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016
Where it was soldUS No recalled product was distributed to any foreign consignees by Lupin.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited Goa 403 722 INDIA foreign manufacturer
Brand nameAMLODIPINE BESYLATE
Generic nameAMLODIPINE BESYLATE
Active ingredient(s)AMLODIPINE BESYLATE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
NDC68180-752-03
Show the full FDA record
Full product labelAmlodipine 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
Recalling firmLupin Limited
DistributionUS No recalled product was distributed to any foreign consignees by Lupin.
Quantity11,812 bottles
Recall initiated2016-02-19
Report date2016-09-14
Recall completed2017-04-03
Recall numberD-1493-2016
ClassificationClass III
FDA statusTerminated
Origin on fileVerna, Salcette, Goa India

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.