FDAFDA · Food and drugs·Recall number D-0682-2017
Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
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: 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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