Undeclared soy lecithin and undeclared color additives Blue 1 Lake, Yellow 6, Red 40, Yellow 5, Blue 1, Yellow 6 Lake, Red 40 Lake, Yellow 5 Lake, Blue 2 Lake, Blue 2.
All Recalls
95,102 total recalls in our database
Berry Buddies; Blueberries, Mini Pancakes & Real Maple Syrup; NET WT 2.1 oz (60 g); 3-compartment non-flex plastic container with heat-sealed plastic film containing mini pancakes, blueberries, and maple syrup
NATURIPE VALUE ADDED FRESH
Incorrect back label on product resulting in undeclared allergens (wheat, eggs)
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Fruit Of The Earth
Chemical contamination: presence of benzene
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
MYLAN PHARMACEUTICALS
Failed Dissolution Specifications - low dissolution results
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Super-Potent Drug: Out of specification potency results were obtained.
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
Slate Run Pharmaceuticals
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug
Chemical contamination: presence of benzene
Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.
One Source Nutrition, Inc,
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Super-Potent Drug: Out of specification potency results were obtained.
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Slate Run Pharmaceuticals
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Golden State Medical Supply
Failed Dissolution Specifications
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Rising Pharma Holding
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
American Contract Systems
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.