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

FDA recall notice · announced August 19, 2020 · Pai Holdings, Llc. Dba Pharmaceutical Associates

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide USA
Lot/code information: Lot: B973, Exp 11/20
Quantity: 7416 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1494-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.