Nystatin Suspension
FDA Recall NDC 0121-0868
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nystatin (NDC 0121-0868). A significant event, classified as Class II, was initiated on Jul 29, 2021 by Pai Holdings, Llc Dba Pai Pharma. The reported reason for this action was: "Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Jul 29, 2021
Aug 18, 2021
a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
Recall Profile & Regulatory Data
Event ID
88392
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Dec 02, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
Affected Packages Involved in this Recall
0121-0868-02Product
0121-0868-16Product
0121-0868-05Product
0121-0868-40Product
0121-0868-50Product
0121-0868-00Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
