FDA-Drug2018-10-17Class III
Amlodipine 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
InvaGen Pharmaceuticals, Inc.
Hazard
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Sold states
Nationwide with the United States
Affected count
2880 bottles
Manufactured in
7 Oser Ave, Hauppauge, NY, United States
Products
Amlodipine 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0012-2019Don't want to check this manually?
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