Drug recall D-0824-2020

Class II Terminated reported Feb 5, 2020

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

Reason for recall

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

Lots and codes

Lots: BB70, BB71 Exp. May 2020

Recall details

Recalling firm
Pharmaceutical Associates Inc, Greenville, SC
Quantity
6288 16 oz bottles
Distribution
Distributed Nationwide in the US
Type
Voluntary: Firm initiated
Recall initiated
January 14, 2020
Terminated
June 3, 2021

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