Major Infants' Gas Relief Drops recalled over sterility concerns

Recall date

September 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0126-2020

FDA classification

Class II

Brand / firm

GCP Laboratories Inc

Sold / distributed

Distributed in MI and further distributed Nationwide.

Why it was recalled

Microbial Contamination of Non-Sterile Product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30