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Jolynn Tumolo
03/03/2022
Perrigo Company is recalling nasal sprays distributed by various retailers throughout the United States after learning they were manufactured using a contaminated excipient that was recalled by the excipient’s supplier. The recalls were included in the March 2, 2022, US Food and Drug Administration (FDA) Enforcement Report.
The recalls were voluntarily initiated by the firm October 26, 2021, and were designated Class II by the FDA on February 23, 2022. The classification communicates that use of the recalled products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
The recall includes the following products:
- Maximum Strength Plus Menthol No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 72288-703-10), from batches 1FK1251 (Exp. 2/28/23) and 1BK0716 (Exp. 12/31/22), distributed by Amazon.com Services;
- Severe Congestion Nasal Spray, No-Drip Plus Menthol, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 50594-719-10), from batch 1BK0827 (Exp. 12/31/22), packaged by Perrigo Company for Big Lots Stores Inc;
- Severe Congestion Nasal Spray, No-Drip Plus Menthol, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 41520-108-10), from batches 1BK0716 (Exp. 12/31/22) and 1FK1251 (Exp. 2/28/23), distributed by Foodhold USA;
- Severe Congestion No-Drip Nasal Spray Plus Menthol, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 55910-511-10), from batches 1BK0716 (Exp. 12/31/22), 1CK0899 (Exp. 1/31/23), and 1FK1163 (Exp. 1/31/23), distributed by Dolgencorp;
- Severe Congestion Nasal Spray, No-Drip Plus Menthol, oxymetazoline hcl 0.05%, 1 fl oz (30 mL) per bottle (NDC 11822-6378-1), from batch 11BK0827 (Exp. 12/31/22), distributed by Rite Aid;
- Severe Congestion Nasal Spray, No-Drip Plus Menthol, oxymetazoline hcl 0.05%, 1 fl oz (30 mL) per bottle (NDC 21130-813-10), from batches 1BK0716 (Exp. 12/31/22), and 1FK1251 and 1HK1196 (Exp. 2/28/23), distributed by Better Living Brands;
- Severe Congestion Nasal Spray, No-Drip Plus Menthol, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 41163-343-10), from batch 1FK1251 (Exp. 2/28/23), distributed by SuperValu Inc.;
- Severe Congestion Nasal Spray, No-Drip Plus Menthol, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 11673-935-10), from batches 1BK0912 (Exp. 12/31/22), 1FK1251 (Exp. 2/28/23), distributed by Target Corp;
- Severe Congestion Nasal Spray, No-Drip Plus Menthol, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 36800-907-10), from batch 1BK0716 (Exp. 12/31/22), distributed by Topco Associates;
- Maximum Strength No-Drip Nasal Spray, oxymetazoline hcl 0.05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 72288-388-10), from batch 1BK0964R (Exp. 1/31/23), distributed by Amazon.com Services;
- Maximum Strength No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 72288-388-10), from batches 1BK0826 (Exp 12/31/22) and 1BK0964R (Exp. 1/31/23), distributed by Amazon.com Services;
- No-Drip Nasal Mist, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 59779-388-10), from batch 1FK1164 (Exp. 1/31/23), distributed by CVS Pharmacy Inc;
- Maximum Strength No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 55910-623-10), from batches 1BK0826 (Exp. 12/31/22), and 1FK1232 and 1BK0964 (Exp. 1/31/23), distributed by Old East Main Co;
- Nasal Spray Decongestant, No-Drip, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 30142-388-10), from batch 1BK0826 (Exp. 12/31/22), distributed by Kroger Co;
- Soothing 12-Hour Nasal Decongestant Spray No-Drip, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 0904-6761-30), from batches 1BK0826 (Exp. 12/31/22) and 1FK1164 (Exp. 1/31/23), distributed by Major Pharmaceuticals;
- Maximum Strength No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 41250-388-10), from batch 1FK1164 (Exp. 1/31/23), distributed by Meijer Distribution, Inc;
- Maximum Strength No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 30142-388-10), from batch 1BK0826 (Exp 12/31/22), distributed by Kroger Co;
- Maximum Strength No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 11822-6319-1), from batches 1BK0964 (Exp. 1/31/23) and 1FK1164 (Exp. 1/31/23), distributed by Rite Aid;
- No-Drip Nasal Decongestant, oxymetazoline hcl .05%, 1 fl oz (30 mL) per bottle (NDC 21130-801-10), from batch 1BK0964 (Exp. 1/31/23), distributed by Better Living Brands;
- No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 41163-703-10), from batch 1BK0964 (Exp. 1/31/23), distributed by SuperValu Inc;
- No-Drip Nasal Spray, oxymetazoline hcl 0.05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 36800-388-10), from batch 1FK1233 (Exp. 1/31/23), distributed by Topco Associates;
- No-Drip Nasal Spray, oxymetazoline hcl .05% nasal decongestant, 1 fl oz (30 mL) per bottle (NDC 49035-388-10), from batches 1CK0897, 1FK1233, and 1FK1232 (Exp. 1/31/23), distributed by Walmart Inc;
- Sinus Severe, oxymetazoline hcl .05% nasal decongestant with menthol, 1 fl oz (30 mL) per bottle (NDC 55910-696-10), from batches 1BK0931 (Exp. 12/31/22), 1CK0900 (Exp. 1/31/23), and 1HK1196 (Exp. 2/28/23), distributed by Dolgencorp; and
- Maximum Strength Nasal Spray, oxymetazoline hcl .05% nasal decongestant with menthol, 1 fl oz (30 mL) per bottle (NDC 41250-989-10), from batch 1BK0716 (Exp. 12/31/22), distributed by Meijer Distribution Inc.
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