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D-053-2013 Class II Terminated

Recalled by New England Compounding Center — Framingham, MA

FDA drug recall D-053-2013 was initiated by New England Compounding Center on October 6, 2012 and is designated Class II. Reason for recall: GMP Deviations 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 Non 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

GMP Deviations

Distribution Pattern

Nationwide Japan

Code Information

All lot codes

Other recalls by New England Compounding Center

D-052-2013 Class II — All Sterile Products manufactured by NECC (New England Compounding Center), Fram (October 6, 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)
D-119-2013 Class II — Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compoun (September 26, 2012)