4 way Nasal Decongestant Fast Acting Nasal Spray — Class III drug recall D-209-2013
Terminated recall by Novartis Consumer Health, reported 2013-03-27, distributed nationwide. Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
| Recall number | D-209-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-03-07 |
| Classified | 2013-03-21 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2014-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | PA |
| Reason classes | labeling |
| NDC | 00067-2086, 00067-2086-01, 00067-2086-05, 00067-2086-15 |
Product
4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-209-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.