Home / Recalls / THE COMPOUNDING SHOP, INC. / D-560-2013

D-560-2013 Class II Terminated

Recalled by THE COMPOUNDING SHOP, INC. — St Petersburg, FL

Recall Details

Product Type
Drugs
Report Date
June 12, 2013
Initiation Date
May 2, 2013
Termination Date
September 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 vials of 10mL each

Product Description

Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

Reason for Recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Distribution Pattern

Florida, California, Minnesota, and Maine

Code Information

All Lots

Other recalls by THE COMPOUNDING SHOP, INC.

  • D-572-2013 Class II — Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papave (May 2, 2013)
  • D-565-2013 Class II — Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding (May 2, 2013)
  • D-559-2013 Class II — Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Sho (May 2, 2013)
  • D-550-2013 Class II — Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, (May 2, 2013)
  • D-555-2013 Class II — Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop (May 2, 2013)
  • D-563-2013 Class II — Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The C (May 2, 2013)
  • D-551-2013 Class II — Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compou (May 2, 2013)
  • D-553-2013 Class II — Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, (May 2, 2013)
  • D-548-2013 Class II — Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop (May 2, 2013)
  • D-562-2013 Class II — Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding S (May 2, 2013)