D-0044-2019 Class II Terminated
FDA drug recall D-0044-2019 was initiated by Product Quest Manufacturing LLC on August 3, 2018 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions that could impact its product quality. The recall status is terminated (terminated March 30, 2021). Affected quantity: 8592 bottles.
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
- 8592 bottles
Product Description
Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.
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.