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Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceut

Recalled February 5, 2020 · FDA recall D-0824-2020 · Pharmaceutical Associates

Hazard
Subpotent: Out of specification for assay at the 12-month time point. · FDA Class II
Units
6288 16 oz bottles
Sold at
Distributed Nationwide in the US

Description

Subpotent: Out of specification for assay at the 12-month time point.

Product
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Manufacturer(s)
Pharmaceutical Associates Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceut | RecallWatchUSA