February 2017 FDA Recall Penicillin V Potassium by Citron Pharma Llc
D-0652-2017 - Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg

This Class III drug recall was voluntarily initiated by Citron Pharma Llc on February 24, 2017 for the product Penicillin V Potassium. The FDA reported the reason for recall as presence of foreign tablet/capsule; amoxicillin 500 mg was found in bottles of penicillin v potassium 500 mg. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0652-2017

Reason for Recall
Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potassium 500 mg
Initiated
02-24-2017
Reported
04-19-2017
Quantity
420 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76738
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Citron Pharma Llc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2019
Product Description About Product Description
Full technical description of the product.
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

57237-040-01 Penicillin V Potassium
57237-040-99 Penicillin V Potassium
57237-041-01 Penicillin V Potassium
57237-041-05 Penicillin V Potassium
57237-041-99 Penicillin V Potassium