FDA-Drug2020-08-19Class II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Hazard
Subpotent drug: Out of specification for assay at the 15-month test interval.
Sold states
Nationwide 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), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1494-2020Don't want to check this manually?
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