Agency classClass IIIOur severity:Low FDA (Drugs)·D-1484-2014·Announced 2014-09-03

Novel Laboratories Recalls Famotidine Oral Suspension Due to Impurity Failure

Novel Laboratories is recalling 25,776 containers of Famotidine Oral Suspension because the product failed an impurity specification. The recall is classified as FDA 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

Novel Laboratories, Inc. is recalling 25,776 containers of Famotidine for Oral Suspension, USP 40 mg/5 mL, Cherry-Banana-Mint Flavored. The product is distributed by Gavis Pharmaceuticals, LLC and is available nationwide. The recall is being conducted because the product failed an impurity/degradation specification at the 12-month stability time point.

The affected product is identified by NDC 43386-500-11. The specific lots involved are M13075A, M13076A, M13076B, M13077A, M13077B (all with expiry date 2/2015) and M13490A (with expiry date 3/2016). 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.

Consumers and healthcare providers should check their inventory for the specific lot numbers and NDC code listed above. If the product is found, it should be returned to the distributor or the manufacturer for credit. No specific instructions for immediate disposal are provided in the source text, but standard recall procedures apply.

The recalled product

Product: FAMOTIDINE (FAMOTIDINE)
Brand: FAMOTIDINE
Manufacturer: Novel Laboratories, Inc.
Category: Drug — Prescription Drug
Hazard: impurity
degradation
Affected units: 25,776

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 (5)

Lot #'s M13075A
M13076A
M13076B
M13077A
M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.

UPCs (1)

0343386500116

Distribution

Distributed nationwide across the United States.

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Same manufacturer · Novel Laboratories, Inc.

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Same hazard · impurity