Nystatin Suspension
FDA Recall NDC 0121-0810
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Nystatin (NDC 0121-0810). A significant event, classified as Class II, was initiated on Aug 04, 2020 by Pharmaceutical Associates, Inc.. The reported reason for this action was: "Subpotent drug: Out of specification for assay at the 15-month test interval."
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
Subpotent drug: Out of specification for assay at the 15-month test interval.
Aug 04, 2020
Aug 19, 2020
7416 bottles
Recall Profile & Regulatory Data
Event ID
86170
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 22, 2021
Product Description
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
Batch or Lot Expiration Information
Lot# Lot: B973, Exp 11/20
Affected Packages Involved in this Recall
0121-0810-02Product
0121-0810-16Product
0121-4810-05Product
0121-4810-40Product
0121-4810-00Product
0121-4810-50Product
Class II Terminated
SubPotent Drug: Low out-of-specification results for assay testing.
Mar 19, 2020
Apr 01, 2020
7416 bottles
Recall Profile & Regulatory Data
Event ID
85302
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Sep 22, 2021
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot: BE85, Exp. 11/2020
Affected Packages Involved in this Recall
0121-0810-02Product
0121-0810-16Product
0121-4810-05Product
0121-4810-40Product
0121-4810-00Product
0121-4810-50Product
Class II Terminated
Subpotent: Out of specification for assay at the 12-month time point.
Jan 14, 2020
Feb 05, 2020
6288 16 oz bottles
Recall Profile & Regulatory Data
Event ID
84712
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pharmaceutical Associates Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US
Termination Date
Jun 03, 2021
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
Batch or Lot Expiration Information
Lot# Lots: BB70, BB71 Exp. May 2020
Affected Packages Involved in this Recall
0121-0810-02Product
0121-0810-16Product
0121-4810-05Product
0121-4810-40Product
0121-4810-00Product
0121-4810-50Product
Class III Terminated
Resuspension problems: Out of specification for appearance and resuspendability.
May 29, 2018
Jun 13, 2018
275400 cups
Recall Profile & Regulatory Data
Event ID
80190
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pharmaceutical Associates Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 13, 2020
Product Description
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Batch or Lot Expiration Information
Lot# Lot: B5B8 Exp. 07/2019
Affected Packages Involved in this Recall
0121-0810-02Product
0121-0810-16Product
0121-4810-05Product
0121-4810-40Product
0121-4810-00Product
0121-4810-50Product
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.
