PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 16, 2019 Initiated: September 18, 2019 #D-0126-2020

Product Description

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

Reason for Recall

Microbial Contamination of Non-Sterile Product.

Details

Recalling Firm
GCP Laboratories Inc
Units Affected
31,392 30 mL bottles
Distribution
Distributed in MI and further distributed Nationwide.
Location
Gulfport, MS

Frequently Asked Questions

What product 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. Recalled by GCP Laboratories Inc. Units affected: 31,392 30 mL bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Product.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 16, 2019. Severity: Moderate. Recall number: D-0126-2020.