FDAClass IINovember 25, 2015

Methylprednisolone/Lidocaine recall: Sterility Concern

Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway…

Why was Methylprednisolone/Lidocaine recalled?

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

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 Numbers: 20150707@31 BUD: 1/3/2016, 20150707@36 BUD: 1/3/2016, 20151106@19 BUD: 12/8/2015, 20151604@24 BUD: 10/13/2015, 20151606@20 BUD: 12/13/2015, 20151805@60 BUD: 11/14/2015, 20152105@35 BUD: 11/17/2015, 20153103@13 BUD: 9/27/2015

Product
Methylprednisolone/Lidocaine (40 mg/mL/1%) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway…
Recalling firm
US Compounding Inc
Quantity
11,363 vials
Distribution
Nationwide
Recall date
November 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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