Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.

Mar 4, 2019 Other Drugs Nationwide View Details →

Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder (UPC 00859667007132), Sunstone Organics Springfield, Oregon 97473, 541-972-3327.

Todd Holiday

Class I - Dangerous

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.

Feb 13, 2019 Other Drugs View Details →

tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA 920, (619) 894-6560.

Mariposa Labs

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.

Nov 12, 2015 Other Drugs View Details →

Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL) Distributed by: Walgreen Co, 200 Wilmont Rd Deerfield IL 60015 NDC 00363-9651-01.

Akorn

Class I - Dangerous

Failed Stability Specification: out of specification results for Sodium Perborate

Feb 4, 2019 Other Drugs Nationwide View Details →

Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86

Oxalis Labs

Class I - Dangerous

Defective Container; complaints of leakage.

Jan 11, 2019 Other Drugs View Details →

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22

US Pharmaceuticals

Class I - Dangerous

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Dec 7, 2018 Other Drugs Nationwide View Details →

Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.

US Pharmaceuticals

Class I - Dangerous

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Dec 7, 2018 Other Drugs Nationwide View Details →

Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03

US Pharmaceuticals

Class I - Dangerous

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

Dec 7, 2018 Other Drugs Nationwide View Details →

GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00

H J Harkins Company Inc

Class I - Dangerous

Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.

Oct 18, 2018 Other Drugs Nationwide View Details →

Glutathione liquid, 100mg/ml

Hiers Enterprises, LLC

Class I - Dangerous

Lack of sterility assurance.

Jan 2, 2019 Other Drugs View Details →

Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.

CBI Laboratories

Class I - Dangerous

Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

Dec 10, 2018 Other Drugs View Details →

Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4

Results RNA

Class I - Dangerous

Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver

Dec 14, 2018 Other Drugs Nationwide View Details →

BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty 3-3cc preloaded syringes. . NDC# 1406000203 UPC 8 72320 00074 5 b) Bulk Kit Net Qty 30mL, NDC# 1406000202, UPC 8 72320 00076 9. Manufactured by CAO (China) Medical Equipment Co. Ltd. for CAO Group, Inc. 4628 West Skyhawk Drive, West Jordan, UT 84084

CAO Group

Class I - Dangerous

cGMP violations noted during the firm's most recent inspection.

Nov 16, 2018 Other Drugs Nationwide View Details →

Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408

AVKARE

Class I - Dangerous

Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product

Nov 20, 2018 Other Drugs View Details →

puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.

Kadesh International

Class I - Dangerous

Non-Sterility: Product manufactured under non-sterile production conditions.

Nov 5, 2018 Other Drugs Nationwide View Details →

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