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New England Compounding Center

FDA Regulatory Profile

Summary

Total Recalls
19 (4 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-053-2013Class IIAll Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A cOctober 6, 2012
D-052-2013Class IIAll Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complOctober 6, 2012
D-112-2013Class IIBetamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manuSeptember 26, 2012
D-120-2013Class IILidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MASeptember 26, 2012
D-110-2013Class IMethylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufacSeptember 26, 2012
D-123-2013Class IISaline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, FraminghSeptember 26, 2012
D-118-2013Class IIHyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding CentSeptember 26, 2012
D-117-2013Class IIGlycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, FramingSeptember 26, 2012
D-116-2013Class IIDexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactureSeptember 26, 2012
D-113-2013Class IIBetamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF InjeSeptember 26, 2012
D-122-2013Class IIOmnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England ComSeptember 26, 2012
D-108-2013Class IMethylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactuSeptember 26, 2012
D-114-2013Class IIBupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England ComSeptember 26, 2012
D-109-2013Class IMethylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactuSeptember 26, 2012
D-124-2013Class IITriamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vialSeptember 26, 2012
D-115-2013Class IIClonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, FramingSeptember 26, 2012
D-119-2013Class IIIsovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, FramingSeptember 26, 2012
D-121-2013Class IILidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New EnglandSeptember 26, 2012
D-111-2013Class IMethylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufacSeptember 26, 2012