New England Compounding Center recalls
New England Compounding Center appears in 19 official U.S. recall notices indexed by RecallRadar, most recently on 2013-01-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 19 |
|---|---|
| Published | 2012-11-21 to 2013-01-09 |
| By agency | FDA Drug (19) |
| By classification | Class II (15), Class I (4) |
| By status | terminated (19) |
| Distribution named in notices | US |
Recalls
- Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 m…
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center,…
FDA Drug · Class I · 2013-01-09 · New England Compounding Center
Reason: Non-Sterility - Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center,…
FDA Drug · Class I · 2013-01-09 · New England Compounding Center
Reason: Non-Sterility - Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center,…
FDA Drug · Class I · 2013-01-09 · New England Compounding Center
Reason: Non-Sterility - Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Fr…
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center,…
FDA Drug · Class I · 2013-01-09 · New England Compounding Center
Reason: Non-Sterility - Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Cen…
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - Triamcinolone 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 vials, manufactured by New England Compoundi…
FDA Drug · Class II · 2013-01-09 · New England Compounding Center
Reason: Lack of Assurance of Sterility - All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on…
FDA Drug · Class II · 2012-11-21 · New England Compounding Center
Reason: GMP Deviations - All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on the…
FDA Drug · Class II · 2012-11-21 · New England Compounding Center
Reason: Lack of Assurance of Sterility