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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: GG80218, Exp. 12/2019
Where it was sold
Nationwide with the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0012-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 3, 2018
- FDA report date
- Oct 17, 2018
- Quantity
- 2880 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0012-2019, exactly as published.
Show all FDA fields
- City
- Hauppauge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81099
- Address
- 7 Oser Ave
- Code information
- Lot #: GG80218, Exp. 12/2019
- Postal code
- 11788-3811
- Report date
- Oct 17, 2018
- Product type
- Drugs
- Recall number
- D-0012-2019
- Classification
- Class III
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Product quantity
- 2880 bottles
- Termination date
- Jul 13, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide with the United States
- Recall initiation date
- Oct 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 11, 2018