Multi-event September 2013 FDA Recall Drug by W.s. Badger Company Inc.
This Multi-event Class II drug recall was voluntarily initiated by W.s. Badger Company Inc. on September 24, 2013 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products; selected lots of badger baby and kids sunscreen lotion were recalled due to microbial contamination.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-325-2014
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
09-24-2013
12-11-2013
5941 Tubes
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.
W.S. Badger Company Inc.
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 and Canada, Greece, Singapore, Thailand, Norway, American Samoa.
04-03-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vanilla, 4 fl. oz.. Tube, UPC Code: 634084490145 (US), UPC code: 634084490169 (Canada)
Batch or Lot Expiration Information
Lot# : 3164A, Exp 06/15
Recall Number: D-324-2014
Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen Lotion were recalled due to microbial contamination.
09-24-2013
12-11-2013
36,272 Tubes
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.
W.S. Badger Company Inc.
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 and Canada, Greece, Singapore, Thailand, Norway, American Samoa.
04-03-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada)
Batch or Lot Expiration Information
Lot# Lot number 3024A EXP 01/15; 3057A EXP 02/15; 3063A EXP 03/15; 3063B EXP 03/15; 3132A; 3133A EXP 05/15.
