Reported Jun 19, 2019 · Terminated

Nasal Decongestant Spray Regular, Oxymetazoline HCl 0.05%, a) 0.5 FL. oz. (15 mL) bottle, NDC:0904-5711-35, b) 1 FL.…

Torrent Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Torrent Pharma Inc · 2091 Hartel Ave · Levittown, PA · 19057-4506

- 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

Lot codes and dates: 62 of 62 codes
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
Amount recalled: 3,788,502 bottles

The agency filed one notice per product. You are reading one of them; the other 40 are below.

28 more are in the archive.

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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