D-0824-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2020
- Initiation Date
- January 14, 2020
- Termination Date
- June 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6288 16 oz bottles
Product Description
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.
Distribution Pattern
Distributed Nationwide in the US
Code Information
Lots: BB70, BB71 Exp. May 2020