Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-41...
FDA Recall #D-0294-2022 — Class II — December 16, 2021
Product Description
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
Reason for Recall
Subpotent
Recalling Firm
Teva Pharmaceuticals USA — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 86,790 and b) 25,416 bottles
Distribution
nationwide
Code Information
a) Lots, 35446365A, Exp 03/2022; 35447040A, Exp 08/2022 & 35447948B, Exp 03/2023. b) Lots 35446318B, Exp 05/2022 & 35447947A, Exp 03/2023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated