Drug recall D-1060-2020
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.
Lots and codes
Lot: BE85, Exp. 11/2020
Recall details
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc, Greenville, SC
- Quantity
- 7416 bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 19, 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.