Penicillin V Potassium Powder, For Solution
FDA Recall NDC 0093-4127
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Penicillin V Potassium (NDC 0093-4127). A significant event, classified as Class II, was initiated on Mar 15, 2021 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "CGMP Deviations: Intermittent exposure to temperature excursion during storage."
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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
91 bottles
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73
Batch or Lot Expiration Information
Lot# 35446365A
Affected Packages Involved in this Recall
0093-1172-01Product
0093-1172-10Product
0093-1174-01Product
0093-1174-10Product
0093-4125-73Product
0093-4125-74Product
0093-4127-73Product
0093-4127-74Product
November 2017 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Nov 28, 2017
Dec 20, 2017
42,384 bottles
Recall Profile & Regulatory Data
Event ID
78641
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Jul 03, 2018
Product Description
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.
Batch or Lot Expiration Information
Lot# 35433115A, Exp 01/18
Affected Packages Involved in this Recall
0093-1172-01Product
0093-1172-10Product
0093-1174-01Product
0093-1174-10Product
0093-4125-73Product
0093-4125-74Product
0093-4127-73Product
0093-4127-74Product
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.
