FDA (Drugs) recall action 80053
The FDA (Drugs) publishes a recall like this one as 12 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 12 pages.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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.
RIJ Pharmaceutical is recalling 228 bottles of RPC APAP Elixir due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical LLC is recalling 1,272 bottles of RPC Children's Non-Aspirin Elixir due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical is recalling 9,240 bottles of Ritussin DM because a water sample showed an out-of-specification total aerobic microbial count.
RIJ Pharmaceutical LLC is recalling Gericare Diocto Liquid because a water sample showed an out-of-specification total aerobic microbial count.
RIJ Pharmaceutical LLC is recalling GeriCare Senna Syrup due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid Extra Strength due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical LLC is recalling RPC Senna Syrup due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical LLC is recalling Geritrex Senna Syrup due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical LLC is recalling Gericare Liquid Pain Relief Acetaminophen due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical LLC is recalling Gericare Iron Supplement Elixir due to out-of-specification microbial counts in a water sample.
RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid because a water sample used in manufacturing showed an out-of-specification total aerobic microbial count.
RIJ Pharmaceutical LLC is recalling Senna Syrup (Sennosides A and B) due to an out-of-specification total aerobic microbial count in a water sample.