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FDAFDA · Food and drugs·Recall number D-0681-2017

Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.

Published May 3, 2017 · Recall initiated: April 6, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Isomeric Pharmacy Solution, LLC
Distributor
Nationwide in the USA and Puerto Rico
Lot
Lot #s: 09007, Exp 04/04/17; 09016, Exp 04/16/17; 09020, Exp 04/18/17; 09025, Exp 04/23/17; 10026, 10030, Exp 05/28/17; 11007, Exp 05/30/17; 11008, Exp 05/31/17; 11020, Exp 06/07/17; 11028, Exp 06/12/17; 11043, Exp 06/26/17.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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