Home / Recalls / Product Quest Manufacturing LLC / D-0048-2019

D-0048-2019 Class II Terminated

Recalled by Product Quest Manufacturing LLC — Daytona Beach, FL

Recall Details

Product Type
Drugs
Report Date
October 24, 2018
Initiation Date
August 3, 2018
Termination Date
March 30, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
102,348 bottles

Product Description

Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

All lots remaining within expiry.

Other recalls by Product Quest Manufacturing LLC

  • D-0079-2019 Class II — Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed (August 3, 2018)
  • D-0040-2019 Class II — Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) (August 3, 2018)
  • D-0060-2019 Class II — Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Str (August 3, 2018)
  • D-0066-2019 Class II — FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Dist (August 3, 2018)
  • D-0058-2019 Class II — Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nas (August 3, 2018)
  • D-0074-2019 Class I — Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bo (August 3, 2018)
  • D-0032-2019 Class II — CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, (August 3, 2018)
  • D-0031-2019 Class II — CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chlor (August 3, 2018)
  • D-0067-2019 Class II — Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, poly (August 3, 2018)
  • D-0042-2019 Class II — Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 (August 3, 2018)