FDA-Drug2020-04-01Class II
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Hazard
SubPotent Drug: Low out-of-specification results for assay testing.
Sold states
Nationwide in the USA.
Affected count
7416 bottles
Manufactured in
1700 Perimeter Rd, N/A, Greenville, SC, United States
Products
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1060-2020Don't want to check this manually?
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