4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Recall Insight

This FDA Drug action (record #D-210-2013) was formally reported on March 27, 2013, with the manufacturer initiating the action on March 7, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Novartis Consumer Health is listed as the recalling firm, operating out of Lincoln, NE. Federal records indicate 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Distribution data in the federal record shows the product reached: Nationwide and Panama. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.