FDAClass IIIDecember 20, 2017

Penicillin V Potassium for Oral Solution recall: Impurity Out of Spec

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…

Why was Penicillin V Potassium for Oral Solution recalled?

Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 35433115A, Exp 01/18

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…
Recalling firm
Teva Pharmaceuticals USA
Quantity
42,384 bottles
Distribution
Nationwide in the USA and Puerto Rico.
Recall date
December 20, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls