Drug recall D-1494-2020
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.
Lots and codes
Lot: B973, Exp 11/20
Recall details
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc, Greenville, SC
- Quantity
- 7416 bottles
- Distribution
- Nationwide USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 4, 2020
- Terminated
- September 22, 2021
Related products
- Nystatin – drug information
- NDC 0121-4810 Nystatin · Nystatin 100000 [USP'U]/mL · Pharmaceutical Associates, Inc.
- NDC 0121-0810 Nystatin · Nystatin 100000 [USP'U]/mL · Pharmaceutical Associates, Inc.