Home / Recalls / THE COMPOUNDING SHOP, INC. / D-571-2013

D-571-2013 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
10 vials of 30 mL each

Product Description

MIC (Methionine, Inositol, and Choline) Injectable, 30 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-565-2013 Class II — Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding (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-559-2013 Class II — Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Sho (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-550-2013 Class II — Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, (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-548-2013 Class II — Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop (May 2, 2013)
  • D-554-2013 Class II — Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Sh (May 2, 2013)
  • D-558-2013 Class II — Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Sho (May 2, 2013)
  • D-572-2013 Class II — Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papave (May 2, 2013)