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D-111-2013 Class I Terminated

Recalled by New England Compounding Center — Framingham, MA

FDA drug recall D-111-2013 was initiated by New England Compounding Center on September 26, 2012 and is designated Class I. Reason for recall: Non-Sterility The recall status is terminated (terminated October 7, 2016). Affected quantity: 3822 vials.

Recall Details

Product Type: Drugs
Report Date: January 9, 2013
Initiation Date: September 26, 2012
Termination Date: October 7, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3822 vials

Product Description

Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

Reason for Recall

Non-Sterility

Distribution Pattern

Nationwide

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-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-120-2013 Class II — Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, F (September 26, 2012)