Home / Recalls / RXQ Compounding LLC / D-0012-2018

D-0012-2018 Class II Terminated

Recalled by RXQ Compounding LLC — Athens, OH

Recall Details

Product Type
Drugs
Report Date
October 25, 2017
Initiation Date
September 25, 2017
Termination Date
December 6, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
945 vials

Product Description

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

Reason for Recall

Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

Distribution Pattern

TX, LA, PA, MA, FL, and OH

Code Information

Lot: 04252017@1, exp 5/9/2018

Other recalls by RXQ Compounding LLC

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  • D-1678-2019 Class II — METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compoundi (June 19, 2019)
  • D-1635-2019 Class II — Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Compo (June 19, 2019)
  • D-1655-2019 Class II — EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West State (June 19, 2019)
  • D-1689-2019 Class II — NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, Uni (June 19, 2019)
  • D-1681-2019 Class II — MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compound (June 19, 2019)
  • D-1653-2019 Class II — EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West Stat (June 19, 2019)
  • D-1676-2019 Class II — MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Compoun (June 19, 2019)
  • D-1696-2019 Class II — PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compoundin (June 19, 2019)
  • D-1716-2019 Class II — VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State Str (June 19, 2019)