Home / Recalls / Isomeric Pharmacy Solution, LLC / D-1480-2016

D-1480-2016 Class II Terminated

Recalled by Isomeric Pharmacy Solution, LLC — Salt Lake City, UT

Recall Details

Product Type
Drugs
Report Date
September 14, 2016
Initiation Date
June 29, 2016
Termination Date
December 20, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
274 multdose vials

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.

Distribution Pattern

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

Code Information

Lots# 03045 and 03046; Exp. 10/16

Other recalls by Isomeric Pharmacy Solution, LLC

  • D-0683-2017 Class II — Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial (April 6, 2017)
  • D-0685-2017 Class II — Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL (April 6, 2017)
  • D-0682-2017 Class II — Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vi (April 6, 2017)
  • D-0684-2017 Class II — Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, (April 6, 2017)
  • D-0686-2017 Class II — Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi- (April 6, 2017)
  • D-0681-2017 Class II — Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vi (April 6, 2017)
  • D-0687-2017 Class II — Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalm (April 6, 2017)
  • D-0518-2017 Class II — Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, R (March 8, 2017)
  • D-1454-2016 Class II — Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 (August 1, 2016)
  • D-0728-2016 Class III — Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial fo (February 2, 2016)