July 2018 FDA Recall Drug by The Hain Celestial Group, Inc. - Worldwide Hq
D-0920-2018 - Incorrect Product Formulation

This Class II drug recall was voluntarily initiated by The Hain Celestial Group, Inc. - Worldwide Hq on July 5, 2018 for the product Drug. The FDA reported the reason for recall as incorrect product formulation. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0920-2018

Reason for Recall
Incorrect Product Formulation: wrong sunscreen product in the package.
Initiated
07-05-2018
Reported
07-25-2018
Quantity
47,128 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80473
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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-28-2018
Product Description About Product Description
Full technical description of the product.
alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.

Batch or Lot Expiration Information

Lot# Lot Codes: a) 7363B, 7363I, 8002C, 8002I, 8054J, 8055B, 8174A; and b) 7353