FDA-Drug2017-05-03Class II
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.
Isomeric Pharmacy Solution, LLC
Hazard
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
4,001 vials
Manufactured in
2401 S Foothill Dr Ste D, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0681-2017Don't want to check this manually?
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