FDA (Drugs) recall action 89205
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.
Microbial Contamination of Non-Sterile 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.
Efficient Laboratories, Inc. is recalling Rompe Pecho DM cough syrup (6 fl oz bottles) due to microbial contamination of the non-sterile product. The recall affects 27,206 bottles distributed nationwide.
Efficient Laboratories is recalling approximately 4,026 bottles of Rompe Pecho Max Multi-Symptoms cough and cold medicine nationwide due to potential microbial contamination of the non-sterile product.
Efficient Laboratories is recalling Rompe Pecho guaifenesin expectorant in 4 fl oz and 6 fl oz bottles due to microbial contamination of non-sterile products. The affected product was distributed nationwide.
Efficient Laboratories is recalling Rompe Pecho CF Cold & Flu Advanced Formula syrup due to microbial contamination of the non-sterile product. The recall affects 10,833 bottles distributed nationwide.