FDA recall D-1060-2020

Product

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.

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2020-03-19

Report date

2020-04-01

Termination date

2021-09-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1060-2020