PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai P…

Recall date

March 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1060-2020

FDA classification

Class II

Brand / firm

PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.