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
Product summary
- 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
Lack of Processing Controls