Lupin Pharmaceuticals Inc.: 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

Is my product affected?

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 TELMISARTAN AND AMLODIPINE

Check against the official notice below — it lists the full affected range.

What happened

Lupin Pharmaceuticals is recalling telmisartan and amlodipine tablets (80 mg/5 mg) in 30-tablet bottles because the medication failed impurities and degradation specifications during an 18-month long-term stability study. The recall affects 12,504 bottles across three lots: G705843 (expiration April 2019), G707763 (expiration August 2019), and G800434 (expiration November 2019).

The recalled product was distributed to six wholesalers and drug chains as well as two mail order pharmacies, which may have distributed it further throughout the United States. The source does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed Impurities/Degradation Specifications; 18 month long term stability study.

Details from the source

Reason for recall: Failed Impurities/Degradation Specifications; 18 month long term stability study. 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. Quantity: 12,504 bottles Lot/code info: G705843 Exp. date April, 2019 G707763 Exp. date August, 2019 G800434 Exp. date November, 2019

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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