Recalls / Class III
Class IIID-0012-2019
Product
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
- Brand name
- Amlodipine Besylate
- Generic name
- Amlodipine Besylate
- Active ingredient
- Amlodipine Besylate
- Route
- Oral
- NDCs
- 69097-126, 69097-127, 69097-128
- FDA application
- ANDA077073
- Affected lot / code info
- Lot #: GG80218, Exp. 12/2019
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.
Recalling firm
- Firm
- InvaGen Pharmaceuticals, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Oser Ave, Hauppauge, New York 11788-3811
Distribution
- Quantity
- 2880 bottles
- Distribution pattern
- Nationwide with the United States
Timeline
- Recall initiated
- 2018-10-03
- FDA classified
- 2018-10-11
- Posted by FDA
- 2018-10-17
- Terminated
- 2021-07-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0012-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.