Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Class I - Dangerous

💊 Drugs Recalled: May 21, 2019 Torrent Pharma Other Drugs

What Should You Do?

Check if you have this product:
Lot #s: a) 17E032, Exp. 05/2019; 17F011; 17F020, Exp. 06/2019; 17G003; 17G011, Exp. 07/2019; 17H016, Exp. 08/2019; 17J005; 17J017; 17J026, Exp. 09/2019; 17K029, Exp. 10/2019; 17L027, Exp. 11/2019; 18A003; 18A004; 18A033, Exp. 01/2020; 18B011, Exp. 02/2020; 18C029, Exp. 03/2020; 18D019; 18D025, Exp. 04/2020; 18F014, Exp. 06/2020; 18H029, Exp. 08/2020; 18J007; 18J018, Exp. 09/2020; 18K007; 18K026, Exp. 10/2020; 19A012, Exp. 01/2021. b) 17E011, Exp. 05/2019; 17E012, Exp. 06/2019; 17G019; 17G023, Exp. 07/2019; 17H011, Exp. 08/2019; 17J029, Exp. 09/2019; 17K005, Exp. 10/2019; 17M005; 17M018, Exp. 12/2019; 18C001; 18C004, Exp. 03/2020; 18F032; 18F019, Exp. 06/2020.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Torrent Pharma Inc
Reason for Recall:: cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL. oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by Major Pharmaceuticals, Livonia MI 48152.

Product Codes/Lot Numbers:

Lot #s: a) 17E032, Exp. 05/2019; 17F011; 17F020, Exp. 06/2019; 17G003; 17G011, Exp. 07/2019; 17H016, Exp. 08/2019; 17J005; 17J017; 17J026, Exp. 09/2019; 17K029, Exp. 10/2019; 17L027, Exp. 11/2019; 18A003; 18A004; 18A033, Exp. 01/2020; 18B011, Exp. 02/2020; 18C029, Exp. 03/2020; 18D019; 18D025, Exp. 04/2020; 18F014, Exp. 06/2020; 18H029, Exp. 08/2020; 18J007; 18J018, Exp. 09/2020; 18K007; 18K026, Exp. 10/2020; 19A012, Exp. 01/2021. b) 17E011, Exp. 05/2019; 17E012, Exp. 06/2019; 17G019; 17G023, Exp. 07/2019; 17H011, Exp. 08/2019; 17J029, Exp. 09/2019; 17K005, Exp. 10/2019; 17M005; 17M018, Exp. 12/2019; 18C001; 18C004, Exp. 03/2020; 18F032; 18F019, Exp. 06/2020.