May 2016 FDA Recall Drug by Bayer Health Care Llc (D-0977-2016 - Labeling; Product Contains Undeclared API (Oxybenzone))
This Class II drug recall was voluntarily initiated by Bayer Health Care Llc on May 10, 2016 for the product Drug. The FDA reported the reason for recall as labeling; product contains undeclared api (oxybenzone). The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0977-2016
Labeling; Product Contains Undeclared API (Oxybenzone)
05-10-2016
06-15-2016
37,512 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bayer Health Care LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-06-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
Batch or Lot Expiration Information
Lot# CV006V9, 2/2018
