Reported Oct 17, 2018 · Terminated
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India,…
InvaGen Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: InvaGen Pharmaceuticals, Inc. · 7 Oser Ave · Hauppauge, NY · 11788-3811
Is this the product you have?
Amlodipine Besylate USP 10 mg Tablets1000-count bottlesRx Only
- Manufactured byCipla Ltd., Verna Goa, India
- Manufactured for
Cipla USAInc. 1560 Sawgrass Corporate ParkwaySuite 130Sunrise FL 33323 UPC 369097128159NDC 69097-128-15
- Lot codes and dates
Lot #: GG80218Exp. 12/2019
- Amount recalled
- 2880 bottles
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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