# FDA recall D-0126-2020

> **GCP Laboratories Inc** · Class II · drug recall initiated 2019-09-18.

## 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

- **Recall number:** D-0126-2020
- **Recalling firm:** GCP Laboratories Inc
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0126-2020. Retrieved 2026-06-15 from https://api.ai-analytics.org/recall/D-0126-2020. Source: US FDA. Licensed CC0.

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