FDAMarch 19, 2020drug

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

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

The hazard

SubPotent Drug: Low out-of-specification results for assay testing.

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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