Why it was recalled
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Product description
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
Lot numbers, UPCs & expiration codes
G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
Where it was sold
Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout 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-1121-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 1, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 12,504 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1121-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82528
- Address
- 111 S Calvert St Fl 21ST
- Code information
- G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
- Postal code
- 21202-6174
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1121-2019
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 12,504 bottles
- Termination date
- Jul 1, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications; 18 month long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
- Distribution pattern
- Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
- Recall initiation date
- Apr 1, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 11, 2019