FDA-Drug2019-06-19Class II
Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
Torrent Pharma Inc
Hazard
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Sold states
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Affected count
14,016 bottles
Manufactured in
2091 Hartel Ave, N/A, Levittown, PA, United States
Products
Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1362-2019Don't want to check this manually?
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