FDA recall D-0126-2020

Product

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.

Distribution

Distributed in MI and further distributed Nationwide.

Key facts

Status

Terminated

Initiation date

2019-09-18

Report date

2019-10-16

Termination date

2021-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gulfport, MS, United States

Primary source

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