The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1127-2017·Announced 2017-09-13

Lupin Recalls Famotidine Oral Suspension Due to Manufacturing Deviations

Lupin Pharmaceuticals is recalling 12,888 bottles of Famotidine for Oral Suspension due to CGMP deviations. The FDA classified this voluntary recall as Class III.

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 FDA classified this recall as 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 Pharmaceuticals Inc. is voluntarily recalling 12,888 bottles of Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottles. The product is prescription-only and was distributed nationwide in the USA. The specific lot affected is G606950 with an expiration date of 07/18.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall was initiated on May 2, 2017, and was terminated on March 28, 2018.

Consumers and healthcare providers should check their inventory for the specific lot number G606950. If the product is found, it should be returned to the pharmacy or supplier for disposal or credit, as directed by the recalling firm.

The recalled product

Product
FAMOTIDINE (FAMOTIDINE)
Brand
FAMOTIDINE
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
12,888

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 #: G606950
  • Exp 07/18

UPCs (1)

  • 0368180150015

Distribution

Distributed nationwide across the United States.

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