Recalls / Class III
Class IIID-1121-2019
Product
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
- Brand name
- Telmisartan And Amlodipine
- Generic name
- Telmisartan And Amlodipine
- Active ingredients
- Amlodipine Besylate, Telmisartan
- Route
- Oral
- NDCs
- 68180-196, 68180-197, 68180-198, 68180-199
- FDA application
- ANDA201586
- Affected lot / code info
- G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019
Why it was recalled
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 12,504 bottles
- 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.
Timeline
- Recall initiated
- 2019-04-01
- FDA classified
- 2019-04-11
- Posted by FDA
- 2019-04-17
- Terminated
- 2020-07-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1121-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.