Recalls / Class II
Class IID-1480-2016
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,
- Affected lot / code info
- Lots# 03045 and 03046; Exp. 10/16
Why it was 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.
Recalling firm
- Firm
- Isomeric Pharmacy Solution, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2401 S Foothill Dr, Salt Lake City, Utah 84109-1479
Distribution
- Quantity
- 274 multdose vials
- Distribution pattern
- Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
Timeline
- Recall initiated
- 2016-06-29
- FDA classified
- 2016-09-02
- Posted by FDA
- 2016-09-14
- Terminated
- 2016-12-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1480-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.