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
Reported: April 17, 2019 Initiated: April 1, 2019 #D-1121-2019
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
Reason for Recall
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 12,504 bottles
- Distribution
- Product was distributed to 6 wholesalers/ drug chains and 2 mail order pharmacies that may have further distribute the product throughout the United States.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 12,504 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications; 18 month long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 17, 2019. Severity: Low. Recall number: D-1121-2019.
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