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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Event Detail

Event ID 63305
Product Type Drugs
Status Ongoing
Recalling Firm New England Compounding Center
City Framingham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-26
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 56,655 vials D-124-2013
Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 54 vials D-123-2013
Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 8919 vials D-122-2013
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 All lot codes Class II Lack of Assurance of Sterility 3,321 vials D-121-2013
Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility D-120-2013
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 7055 vials D-119-2013
Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 10,865 vials D-118-2013
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 165 vials D-117-2013
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, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 20 vials D-116-2013
Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility 2747 vials D-115-2013
Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility D-114-2013
Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility D-113-2013
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA All lot codes Class II Lack of Assurance of Sterility D-112-2013
Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility 3822 vials D-111-2013
Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility 5130 vials D-110-2013
Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All lot codes Class I Non-Sterility 9062 vials D-109-2013
Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA All Lot codes Class I Non-Sterility 23,897 vials D-108-2013
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