September 2019 FDA Recall Drug by Gcp Laboratories Inc
D-0126-2020 - Microbial Contamination of Non-Sterile Product.

This Class II drug recall was voluntarily initiated by Gcp Laboratories Inc on September 18, 2019 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0126-2020

Reason for Recall
Microbial Contamination of Non-Sterile Product.
Initiated
09-18-2019
Reported
10-16-2019
Quantity
31,392 30 mL bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83835
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
GCP Laboratories Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in MI and further distributed Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-05-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot: WBD003 Exp. 03/21