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Recall Observatory FDA recall evidence

Drug product

Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,

D-1480-2016

June 29, 2016

Class II

Product summary

Firm
Isomeric Pharmacy Solution, LLC
Event
Event 74603
Status
Terminated
Classification
Class II
Quantity
274 multdose vials
Official record key
drug-enforcement:D-1480-2016

Official wording

Reason: Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.

Code information: Lots# 03045 and 03046; Exp. 10/16

Distribution pattern: Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls