FDAClass IIJanuary 17, 2018

T-105 (Prostaglandin E1 recall: Labeling Error

T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791…

Why was T-105 (Prostaglandin E1 recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

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: 07122017@2 BUD: 1/8/2018

Product
T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For Intracavernouse Use, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791…
Recalling firm
KRS Global Biotechnology, Inc
Quantity
173 vials
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Recall date
January 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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