December 2021 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0294-2022 - Subpotent

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on December 16, 2021 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0294-2022

Reason for Recall
Subpotent
Initiated
12-16-2021
Reported
12-29-2021
Quantity
a) 86,790 and b) 25,416 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89255
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
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.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2022
Product Description About Product Description
Full technical description of the product.
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

Batch or Lot Expiration Information

Lot# a) Lots, 35446365A, Exp 03/2022; 35447040A, Exp 08/2022 & 35447948B, Exp 03/2023. b) Lots 35446318B, Exp 05/2022 & 35447947A, Exp 03/2023.