PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL)
Recalled August 18, 2021 · FDA recall D-0721-2021 · PAI Holdings, LLC.
Hazard
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. · FDA Class II
Units
a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
Sold at
Distributed Nationwide in the USA
Description
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Product
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
Manufacturer(s)
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →