FDA-Drug2019-10-16Class II

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

GCP Laboratories Inc
Hazard

Microbial Contamination of Non-Sterile Product.

Sold states
Distributed in MI and further distributed Nationwide.
Affected count
31,392 30 mL bottles
Manufactured in
3600 25th Ave, N/A, Gulfport, MS, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0126-2020

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