FDA recall D-1494-2020

Product

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

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2020-08-04

Report date

2020-08-19

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-1494-2020