FDAClass IIMay 3, 2017

Methylprednisolone Acetate 80 mg/mL recall: Sterility Concern

Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill…

Why was Methylprednisolone Acetate 80 mg/mL recalled?

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

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 #s: 09022, Exp 04/22/17; 10001, Exp 05/02/17; 11001, Exp 05/31/17; 11010, Exp 06/03/17; 11037, Exp 06/19/17; 11041, Exp 06/25/17.

Product
Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill…
Recalling firm
Isomeric Pharmacy Solution, LLC
Quantity
2,352 vials
Distribution
Nationwide in the USA and Puerto Rico
Recall date
May 3, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls