RecallDepth
Class III Terminated

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

Company
Invagen Pharmaceuticals, Inc.
Recall Initiated
October 3, 2018
Posted
October 17, 2018
Recall Number
D-0012-2019
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
2880 bottles
Firm Location
Hauppauge, NY, United States

Reason for Recall

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

Distribution

Nationwide with the United States

Lot / Code Info

Lot #: GG80218, Exp. 12/2019

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