FDAAugust 4, 2020drug

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

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

The hazard

Subpotent drug: Out of specification for assay at the 15-month test interval.

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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