Lupin Limited: Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 I

Is my product affected?

Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-752-03

• Brand AMLODIPINE BESYLATE

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

What happened

Lupin Limited is recalling 11,812 bottles of Amlodipine Besylate Tablets USP 10mg in 1000-count bottles manufactured for Lupin Pharmaceuticals, Inc. The recall affects 12 specific lots (G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534) with expiration dates of 4/2016. The tablets are being recalled due to manufacturing deviations involving active pharmaceutical ingredients whose intermediates failed to meet specifications. The recalled product was only distributed within the United States.

The recall notice does not specify a remedy or action that affected consumers should take.

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

Hazard

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Details from the source

Reason for recall: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Distribution: US No recalled product was distributed to any foreign consignees by Lupin. Quantity: 11,812 bottles Lot/code info: Lot #: G304677, G304540, G304536, G304537, G304535, G304541, G304545, G304533, G304532, G304539, G304538, G304534, Exp. 4/2016

Source

Official record: FDA (Drug enforcement) ↗

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

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