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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 #: GG80218, Exp. 12/2019
Where it was soldNationwide with the United States
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

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

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 byCipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159 foreign manufacturer
Brand nameAMLODIPINE BESYLATE
Generic nameAMLODIPINE BESYLATE
Active ingredient(s)AMLODIPINE BESYLATE
Distributed by / forCipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159
NDC69097-128-15
Show the full FDA record
Full product labelAmlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
Recalling firmInvaGen Pharmaceuticals, Inc.
DistributionNationwide with the United States
Quantity2880 bottles
Recall initiated2018-10-03
Report date2018-10-17
Recall completed2021-07-13
Recall numberD-0012-2019
ClassificationClass III
FDA statusTerminated
Origin on fileHauppauge NY United States

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.