FDA (Drugs) recall action 93708
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Seaway Pharma is recalling oxymetazoline nasal spray due to manufacturing process deviations. No contamination was found in the final products.
Quality Choice No Drip Nasal Decongestant is being recalled because purified water used in manufacturing may have contained microbial contamination. No contamination was detected in the final products.
Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.
Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.