The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1492-2016·Announced 2016-09-14

Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Lupin Limited is recalling Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles. The recall involves 43,536 bottles of the prescription medication, identified by Lot # G304799 and an expiration date of 4/2016. The product was manufactured in India for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and distributed only within the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed specifications. This indicates a potential quality control issue during the manufacturing process.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement. The recall is classified as Class III by the FDA, which indicates that the product is not likely to cause adverse health consequences.

The recalled product

Product
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
Brand
AMLODIPINE BESYLATE
Manufacturer
Lupin Limited
Category
Drug — Prescription Drug
Hazard
Affected units
43,536

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: G304799
  • Exp. 4/2016

UPCs (1)

  • 0368180233022

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Lupin Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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