FDAClass IIOctober 18, 2017

Glutamine recall: Impurity Out of Spec

Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd…

Why was Glutamine recalled?

CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed

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: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18

Product
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd…
Recalling firm
United Pharmacy
Quantity
268 vials
Distribution
Nationwide.
Recall date
October 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls