Tag: alerts

FDA Investigates Multi State Outbreak (Recall List)

The FDA is advising health professionals and consumers to avoid using products that have been recalled by Shadow Holdings dba Bocchi Laboratories as they might be contaminated with bacteria within the Burkholderia cepacia complex, also commonly called Bcc. The FDA is investigating whether other products manufactured by Shadow Holdings dba Bocchi Laboratories may be contaminated with Bcc and present a risk to consumers. The FDA is currently advising health professionals and consumers to avoid using products that have been recalled by Shadow Holdings dba Bocchi Laboratories, as these products may be contaminated with the bacteria Burkholderia cepacia complex (Bcc). The FDA is particularly concerned about potential contamination in recalled lots of Medline Remedy Essentials No-Rinse Cleansing Foam, since laboratory analysis by the FDA confirmed that samples of this product contained Bcc matches Bcc isolates collected from the Shadow Holdings dba Bocchi Laboratories facility and from ill persons. The matches were detected by pulsed field gel electrophoresis (PFGE), a type of DNA fingerprinting. Shadow Holdings dba Bocchi Laboratories has recalled other products made in the same location.

Current Recalls

Shadow Holdings DBA Bocchi Labs recalls Eufora BEAUTIFYING ELIXIR BODIFYING CONDITIONER, 1.7 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls Eufora BEAUTIFYING ELIXIR BODIFYING CONDITIONER, 1.7 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls Eufora NOURISH HYDRATING SHAMPOO, 8.45 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls John Paul Mitchell NEURO REPAIR HEAT CONTROL BLOWOUT PRIMER, 0.85 oz. and 4.7 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls John Paul Mitchell INVISIBLEWEAR MEMORY SHAPER, 8.5 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls John Paul Mitchell SUPER SCULPT GLAZE, 8.5 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls John Paul Mitchell NEURO LATHER HEAT CONTROL SHAMPOO, 9.2 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls John Paul Mitchell NEURO LATHER HEAT CONTROL CONDITIONER, 9.2 oz. due to potential contamination with Burkholderia cepacia complex (Bcc.). FDA has confirmed the presence of the bacteria in some lots of foaming cleanser.

Shadow Holdings DBA Bocchi Labs recalls Medline Remedy Essentials No Rinse Foaming Cleanser: No Rinse Foam; CHG Compatible, pH balanced, Fragrance Free – for all ages 4oz (MSC092FBC04): 24 bottles/case; 8oz bottles (MSC092FBC08): 12 bottles/case; Ingredient: Water, TEA-Lauryl Sulfate, Aloe Barbadenis, Propylene Glycol, Sodium Lauryl Lacitylate, Iodopropronyl, Butylcarbamate, DMDM Hydanton Triethanolamine, Citric Acid. Manufactured for Medline Industries, Inc. Northfield, IL www.Medline.com; Item number MSC092FBC04; lots M06691, M07247 ; Item number MSC092FBC08; lots M05703 and M06691, due to  potential contamination with Burkholderia cepacia.

Avlon Industries, Inc recalls KeraCare Hydrating Detangling Shampoo—Sulfate-free, 8 oz., and gallons; 8 oz.-12 bottles/case; gallons-4 per case; UPC 9670838012, Item #53227; UPC: 9670833053, Item #53943 (Lot 16G1503 and Lot 16K3I03) due to the presence of Enterobacter cloacae.

The resources listed below are related to recalls of cosmetics and other products regulated by FDA, as well as other safety alerts related to cosmetics. To learn about FDA’s role in recalls of cosmetics, see FDA Recall Policy for Cosmetics.