The Recall Desk

FDA (Drugs) recall action 80750

Product Quest Manufacturing LLC recalled 54 products on 2018-10-24

The FDA (Drugs) publishes a recall like this one as 54 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 54 pages.

Products
54
Announced
2018-10-24
Critical
1
Units
7,981,021

Why these products were recalled

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Superpotent Drug: high out of specification assay results for the camphor ingredient.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–54 of 54

  • ModerateFDA (Drugs)··2018-10-24

    Product Quest Recalls OCEAN Saline Nasal Spray Due to Quality Deviations

    Product Quest Manufacturing LLC is recalling OCEAN Saline Nasal Spray bottles nationwide because they were manufactured under conditions that could impact product quality.

    Product
    OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Divis
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-10-24

    Walgreens Anefrin Nasal Spray Recalled for Manufacturing Quality Issues

    Product Quest Manufacturing LLC is recalling 355,056 bottles of Walgreens Anefrin Nasal Spray due to manufacturing conditions that could impact product quality.

    Product
    Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-10-24

    Saline Nasal Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing LLC is recalling Discount Drug Mart and Food Fair Saline Nasal Spray due to manufacturing deviations that could impact product quality.

    Product
    Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2018-10-24

    Product Quest Recalls CareOne Saline Nasal Gel Due to Quality Concerns

    Product Quest Manufacturing LLC is recalling CareOne Saline Nasal Gel With Soothing Aloe because it was manufactured under conditions that could impact product quality.

    Product
    CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.
    Category
    Distribution
    0 states