November 2017 FDA Recall Penicillin V Potassium by Teva Pharmaceuticals Usa
D-0108-2018 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on November 28, 2017 for the product Penicillin V Potassium. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0108-2018
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
11-28-2017
12-20-2017
42,384 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico.
07-03-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
