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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall must be scored as 4 (Severe), regardless of the absence of reported injuries in the provided text.
Plain-English summary
Product Quest Manufacturing LLC is recalling 355,056 bottles of Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%). The product is a 0.5 FL OZ (15 mL) nasal decongestant distributed by Walgreen Co. The recall covers all lots remaining within their expiry dates.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the products were manufactured under conditions that could impact product quality. The FDA has classified this recall as Class II.
The affected product was distributed nationwide in the USA. Consumers should check their medicine cabinets for this specific product, identified by NDC 0363-7005-01 and UPC 3 11917 18537 8. If found, consumers should stop using the product and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.
The recalled product
- 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.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Decongestant
- Hazard
- Affected units
- 355,056
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Product Quest Manufacturing LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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