Drug product
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
D-0721-2021
Product summary
- Event
- Event 88392
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
- Official record key
drug-enforcement:D-0721-2021
Official wording
Reason: Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Code information: Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
Lack of CGMP