Product Quest Recalls OCEAN Saline Nasal Spray Due to Quality Deviations
Product Quest Manufacturing LLC is recalling OCEAN Saline Nasal Spray bottles nationwide because they were manufactured under conditions that could impact product quality.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deviations that could impact product quality, but no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Product Quest Manufacturing LLC is voluntarily recalling OCEAN Saline Nasal Spray in 3.5 Fl. Oz. (104 mL) bottles, 45 cc (1.5 fl. oz.) bottles, and Buddy Packs containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton. The recall covers 3,442,536 bottles distributed nationwide in the USA by Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC. All lots remaining within their expiry dates are affected.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, meaning the products were manufactured under conditions that could impact product quality. The source text does not specify the exact nature of the deviations or report any illnesses or injuries associated with the product.
Consumers who have purchased OCEAN Saline Nasal Spray should check their bottles for the affected UPC codes and sizes. The source text does not provide specific instructions for consumers on how to return the product or obtain a refund.
The recalled product
- Product
- OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Divis
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 3,442,536
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Product Quest Manufacturing LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 54 products in this recall →Related recalls
Same manufacturer · Product Quest Manufacturing LLC
See all →- ModeratePremier Value Sterile Saline Nasal Mist Recalled for Quality Concerns
FDA (Drugs) · 2018-10-24
- ModerateRhinall Nasal Decongestant Spray Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2018-10-24
- ModerateRhinall Nasal Decongestant Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2018-10-24
- ModerateCVS Health Saline Nasal Spray Recalled for Manufacturing Deviations
FDA (Drugs) · 2018-10-24
- ModerateRite Aid Nasal Spray Recalled for Manufacturing Quality Deviations
FDA (Drugs) · 2018-10-24
Same hazard · quality deviation
See all →- ModerateNarcan Nasal Spray Recalled for Temperature Excursions During Storage
FDA (Drugs) · 2021-06-02
- ModerateCardinal Health Recalls Meloxicam Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateCardinal Health Recalls LYRICA Capsules Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateCardinal Health Recalls Advair HFA Inhalers Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateCardinal Health Recalls Oseltamivir Phosphate Oral Suspension Due to Temperature Excursions
FDA (Drugs) · 2021-06-02