FDA-Drug2020-02-05Class II

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

Pharmaceutical Associates Inc
Hazard

Subpotent: Out of specification for assay at the 12-month time point.

Sold states
Distributed Nationwide in the US
Affected count
6288 16 oz 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, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0824-2020

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