Seaway Pharma Inc. FDA Recalls

4 recalls on file across drugs, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant,Class IIDec 28, 2023CGMP Deviations: Firm reported possible microbial contaminat	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturin	Class IIDrugs	Dec 28, 2023
Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 HourClass IIDec 28, 2023CGMP Deviations: Firm reported possible microbial contaminat	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturin	Class IIDrugs	Dec 28, 2023
Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality ChClass IIDec 28, 2023CGMP Deviations: Firm reported possible microbial contaminat	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturin	Class IIDrugs	Dec 28, 2023
Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL OClass IIDec 28, 2023CGMP Deviations: Firm reported possible microbial contaminat	CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturin	Class IIDrugs	Dec 28, 2023