July 2018 FDA Recall Drug by The Hain Celestial Group, Inc. - Worldwide Hq
D-1078-2018 - Microbial Contamination of a Non-Sterile Product

This Class II drug recall was voluntarily initiated by The Hain Celestial Group, Inc. - Worldwide Hq on July 25, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of a non-sterile product. The product was distributed in Product was distributed to one distributor in California who may have distributed the product further within the US. and the recall is currently terminated.

Recall Number: D-1078-2018

Reason for Recall
Microbial Contamination of a Non-Sterile Product
Initiated
07-25-2018
Reported
08-22-2018
Quantity
1,098 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80648
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.
The Hain Celestial Group, Inc. - Worldwide HQ
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.
Product was distributed to one distributor in California who may have distributed the product further within the US.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2019
Product Description About Product Description
Full technical description of the product.
alba BOTANICA Sensitive Sheer Shield Sunscreen Fragrance Free spf 50+ , 85 g 3 oz tube. Manufactured by: The Haine Celestial Group, Inc. Lake Success, NY, UPC 7 24742 00438 5

Batch or Lot Expiration Information

Lot# Lot code 8041