FDA Drug recall D-1354-2019
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, ND…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of 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, ND… by Torrent Pharma, citing cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1354-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-21 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
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.
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Identifiers
| code_info | Lot #s: a) 17E032, Exp. 05/2019; 17F011; 17F020, Exp. 06/2019; 17G003; 17G011, Exp. 07/2019; 17H016, Exp. 08/2019; 17J0…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1354-2019%22
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