FDA-Drug2021-08-18Class II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Hazard
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Sold states
Distributed Nationwide in the USA
Affected count
a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
Manufactured in
1700 Perimeter Rd, N/A, Greenville, SC, United States
Products
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0721-2021Don't want to check this manually?
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