Reported Oct 16, 2019 · Terminated

Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major…

GCP Laboratories Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: GCP Laboratories Inc · 3600 25th Ave · Gulfport, MS · 39501-6922

Is this the product you have?

  • Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle
  • Distributed byMajor Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
Lot codes and dates
  • LotWBD003 Exp. 03/21
Amount recalled
31,392 30 mL bottles

Where it was sold

  • Nationwide
  • MI

Why it was recalled

Microbial Contamination of Non-Sterile Product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 5, 2021 · Data as of Sep 19, 7:56 PM UTC

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