FDA Recall D-0569-2024

Neilmed Pharmaceuticals Inc · Santa Rosa, CA

Class III Ongoing 689 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

Lot / code: Lot: SD134; Exp: 10/31/2026

Quantity: 20,370 bottles

Reason for recall

Sub-potent Drug

Recall record

Recall number: D-0569-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the US
Recall initiated: 2024-06-24
Classified by FDA Center: 2024-06-28
FDA published: 2024-07-03
Recalling firm: Neilmed Pharmaceuticals Inc
Firm location: Santa Rosa, CA

Drug identification

Brand name(s): SINUFRIN QUICK RELIEF DECONGESTANT
Generic name(s): SINUFRIN
Manufacturer(s): Neilmed pharmaceuticals Inc.
NDC(s): 13709-325
Route(s): NASAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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