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.

FDA recall notice · announced April 1, 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) 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.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot: BE85, Exp. 11/2020
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) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16. (D-1060-2020)

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