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THE COMPOUNDING SHOP, INC.

FDA Regulatory Profile

Summary

Total Recalls
25
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-562-2013Class IIProcaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg,May 2, 2013
D-572-2013Class IITri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded byMay 2, 2013
D-565-2013Class IIPhosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. PetersburMay 2, 2013
D-559-2013Class IILipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FMay 2, 2013
D-550-2013Class IIBaclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FLMay 2, 2013
D-555-2013Class IIDexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FLMay 2, 2013
D-563-2013Class IIAscorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St.May 2, 2013
D-551-2013Class IIBaclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. PeteMay 2, 2013
D-553-2013Class IIBetamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FLMay 2, 2013
D-548-2013Class IIMethotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FLMay 2, 2013
D-564-2013Class IIB-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FLMay 2, 2013
D-560-2013Class IIMitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FLMay 2, 2013
D-554-2013Class IIDexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, May 2, 2013
D-558-2013Class IIGlutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FMay 2, 2013
D-552-2013Class IIBaclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, May 2, 2013
D-570-2013Class IIPraziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FLMay 2, 2013
D-568-2013Class IIMorphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. PetersburgMay 2, 2013
D-566-2013Class IIMIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounMay 2, 2013
D-556-2013Class IIHydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The CompounMay 2, 2013
D-561-2013Class IIMethylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. PetersMay 2, 2013