Home / Recalls / New England Compounding Center / D-112-2013

D-112-2013 Class II Terminated

Recalled by New England Compounding Center — Framingham, MA

FDA drug recall D-112-2013 was initiated by New England Compounding Center on September 26, 2012 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated October 7, 2016). Affected quantity: N/A.

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
N/A

Product Description

Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide

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-053-2013 Class II — All Non Sterile Products manufactured by NECC (New England Compounding Center), (October 6, 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)

FDA data resources