FDAJuly 29, 2021drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

What to do

FDA enforcement status: Terminated

Brands named

pai holdings llc dba pharmaceutical associatespaipai holdings

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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