Penicillin V Potassium Tablet, Film Coated
FDA Recall NDC 57237-040
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 Penicillin V Potassium (NDC 57237-040). A significant event, classified as Class III, was initiated on Feb 24, 2017 by Rising Health, Llc. The reported reason for this action was: "Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg"
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
February 2017 Class III Recall: Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Recall Number
Class III Terminated
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Feb 24, 2017
Apr 19, 2017
420 bottles
Recall Profile & Regulatory Data
Event ID
76738
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Citron Pharma Llc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 09, 2019
Product Description
Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles, Rx Only, Distributed by: Citron Pharma LLC, East Brunswick, NJ --- NDC 57237-041-99
Batch or Lot Expiration Information
Batch# Batch Numbers: PE5015069-A, exp 11/2018
Affected Packages Involved in this Recall
57237-040-01Product
57237-040-99Product
57237-041-01Product
57237-041-05Product
57237-041-99Product
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.
