D-0063-2019 Class II Terminated
FDA drug recall D-0063-2019 was initiated by Product Quest Manufacturing LLC on Aug 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 Mar 30, 2021). Affected quantity: 355,056 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 355,056 bottles
Product Description
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.
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0063-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026