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Showing 1161–1180 of 2521 results

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Make Up Perfect Terra SPF 10 (Linde Eckstein) - Subpotent Protection (2017)

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

FDAJul 17, 2017Nationwide• Linde Eckstein Gmbh + Co KG

Make Up Perfect Pastel SPF 10 (Linde Eckstein) - Subpotent Protection (2017)

Subpotent Drug: products are labeled as having SPF 10 protection; however, this claim cannot be 100% guaranteed.

FDAJul 17, 2017Nationwide• Linde Eckstein Gmbh + Co KG

Magnesium Citrate Oral Solution (Vi-Jon) – Microbial Contamination (2017)

Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.

Class IIModerate

FDAJul 17, 2017GA, NJ, PA• Vi-Jon, Inc.

Comforts Baby Purified Water (Kroger) – Mold Contamination (2017)

the firm received a complaint of mold found in the product.

Class IIModerate

FDAJul 3, 2017AL, AR, GA +12 more• The Kroger Co

Infant Coveralls (Burt's Bees) – Choking Hazard (2017)

This recall involves infant Butterfly Garden Coverall & Hat Sets. The coveralls are 100% organic cotton, and were sold in blossom pink with white butterflies. There is a white ruffle around the neck that runs down the front of the garment. It has snaps in the crotch and was sold in infant sizes NB, 3M, 6M, and 9M. The manufacture date code of August 2016 (08/2016) is printed on the inside garment tag located inside the seam of the garment. "Burt's Bees Baby" and the garment sizes are printed on the inside back of the garment. Only coverall sets with style number LY24195 on the hangtag are included in the recall.

CPSCJun 29, 2017Nationwide

Ginseng Classic (Threshold Enterprises) – Coliform Growth (2017)

Product was inadvertently released prior to release of all QC testing. Testing had positive results for coliform growth.

Class IIModerate

FDAJun 16, 2017CA, IL, ME +4 more• Threshold Enterprises Ltd

Baby Eczema Cream (CVS Health) – microbial contamination (2017)

Microbial Contamination of Non Sterile Products; out of specification Total Plate Count

Class IIModerate

FDAJun 13, 2017CA• Sigan Industries Inc.

Magnesium Citrate Laxative (Vi-Jon) – glass particle (2017)

Presence of foreign substance: glass particle

Class IIModerate

FDAJun 12, 2017Nationwide• Vi-Jon, Inc.

Gaviscon Chewables (Sanofi-Aventis) – high magnesium levels (2017)

Superpotent Drug: high out-of-specification result for magnesium.

FDAJun 12, 2017Nationwide• Sanofi-Aventis U.S. LLC

StingMed Insect Skin Protectant (Phillips) – Manufacturing Deviation (2017)

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

Class IIModerate

FDAJun 8, 2017Nationwide• Phillips Co.

VenomX Skin Protectant (Phillips) – Manufacturing Deviation (2017)

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

Class IIModerate

FDAJun 8, 2017Nationwide• Phillips Co.

StaphWash Skin Protectant (Phillips) – Manufacturing Deviation (2017)

GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

Class IIModerate

FDAJun 8, 2017Nationwide• Phillips Co.

NasalCrom Nasal Spray (Bausch & Lomb) – Contamination Risk (2017)

CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.

Class IIModerate

FDAJun 6, 2017Nationwide• Bausch & Lomb, Inc.

Walgreens Cold & Flu (Perrigo) – Packaging Error (2017)

Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the product twin pack. The incorrect product sleeve is for Day-Night Cold and Flu whereas the batch contains Day-Night Cough Liquid.

FDAJun 5, 2017IL• L. Perrigo Company

Combi Shuttle Travel System – Fall Risk (2017)

This recall involves Combi Shuttle model strollers and car seats, which when used together are called a travel system. The strollers and car seats have model number 6100027 or 6100100 printed on a label on the base of the car seat and stroller's leg. The car seat and stroller were sold in titanium (silver) and red chili (red) colors. Combi is printed on the front of the stroller and the car seat. Shuttle is printed above the model number.

CPSCMay 4, 2017Nationwide

Infant Cozie Booties (Zutano) – Choking Risk (2017)

This recall involves infant fleece gripper Cozie booties. They are 70 percent cotton and 30 percent polyester. The booties have rubber grippers in the shape of a "Z" on the bottom. These booties were sold in sizes 12 - 18 months in 13 solid colors; chocolate, gray, heather gray, hot pink, pool (aqua), apple (light green), cream, fuchsia, lime, mandarin, navy, pagoda (turquoise blue) and periwinkle and in multi-colors. Only booties with the following tracking labels sewn under the care label are included in this recall. Tracking numbers: FALL161-03/16 FALL166-03/16 FALL166-06/16 FALL167-06/16 FALL168-07/16 FALL169-07/16 FALL1610-08/16 FALL1611-09/16 FALL1612-07/16

CPSCApr 25, 2017Nationwide

Baby Teething Tablets (Hyland's) – Alkaloid Inconsistency (2017)

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

FDAApr 13, 2017Nationwide• Standard Homeopathic Company

Baby Nighttime Teething Tablets (Hyland's) – Alkaloid Inconsistency (2017)

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

FDAApr 13, 2017Nationwide• Standard Homeopathic Company

Estradiol USP Bulk (Medisca) – cGMP deviation (2017)

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Class IIModerate

FDAApr 3, 2017Nationwide• Medisca, Inc.

Estrone USP Bulk (Medisca) – cGMP deviation (2017)

cGMP Deviations; manufacturer initiated recall of API product after deficiencies noted during a recent FDA inspection

Class IIModerate

FDAApr 3, 2017Nationwide• Medisca, Inc.

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