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,
Reported: September 14, 2016 Initiated: June 29, 2016 #D-1480-2016
Product Description
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,
Reason for Recall
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.
Details
- Recalling Firm
- Isomeric Pharmacy Solution, LLC
- Units Affected
- 274 multdose vials
- Distribution
- Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by Isomeric Pharmacy Solution, LLC. Units affected: 274 multdose vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2016. Severity: Moderate. Recall number: D-1480-2016.
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