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D-052-2013 Class II Terminated

Recalled by New England Compounding Center — Framingham, MA

FDA drug recall D-052-2013 was initiated by New England Compounding Center on October 6, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated October 7, 2016).

Recall Details

Product Type: Drugs
Report Date: November 21, 2012
Initiation Date: October 6, 2012
Termination Date: October 7, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide Japan

Code Information

All lot codes

Other recalls by New England Compounding Center

D-053-2013 Class II — All Non Sterile Products manufactured by NECC (New England Compounding Center), (October 6, 2012)
D-118-2013 Class II — Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New Engl (September 26, 2012)
D-112-2013 Class II — Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/ (September 26, 2012)
D-110-2013 Class I — Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and (September 26, 2012)
D-121-2013 Class II — Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufac (September 26, 2012)
D-115-2013 Class II — Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compoun (September 26, 2012)
D-124-2013 Class II — Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, (September 26, 2012)
D-116-2013 Class II — Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL P (September 26, 2012)
D-113-2013 Class II — Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosph (September 26, 2012)
D-122-2013 Class II — Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufacture (September 26, 2012)