Drug recall
Eye Drops Allergy Relief, (Naphazoline hydrochloride 0.012% Glycerin 0.2%, Zinc Sulfate 0.25%), 20 mL (.67 LF…
FDA recall event 28425 · Class I, Class II · Natureplex Llc
Key facts
| Event ID | 28425 |
|---|---|
| Recall numbers | D-175-4, D-176-4, D-177-4, D-178-4 |
| Recalling firm | Natureplex Llc |
| Product type | Drugs |
| Products | Eye Drops Allergy Relief, (Naphazoline hydrochloride 0.012% Glycerin 0.2%, Zinc Sulfate 0.25%), 20 mL (.67 LF OZ) plastic bottles, over-the-counter, NATUREPLEX, Memphis, TN 38112, NDC 67234-011-01, Eye Drops Artificial Tears, (Polyvinyl alcohol 0.5% and Povidone 0.6%), 20 mL (.67 FL OZ), over-the-counter, NATUREPLEX, Memphis, TN 38112, NDC 67234-009-01, Eye Drops, Extra Relief, (Naphazoline hydrochloride 0.012% Glycerin 0.2%, 20 mL (.67 FL OZ) plastic bottles, over-the-counter, MADE IN THE USA NATUREPLEX, Memphis, TN 38112, NDC 67234-010-01, No Drip Nasal Spray, (Oxymetazoline 0.05%), 20 mL (.67 FL OZ) plastict bottles, 12 Hour Pump Mist, over-the-counter, Made in the USA by Natureplex, Memphis, TN 38112, NDC 67234-012-01 |
| Classification | Class I, Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of assurance of sterility, Non sterile; microbial contamination (Paenibacillus alvei), Non sterile; product manufactured under nonsterile conditions, Non sterile; product manufactured under unsterile conditions |
| Initiation date | Mar 1, 2004 |
| City | Memphis |
| Country | United States |
| FEI number | 3003631744 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports