Class II · Moderate risk
All Sterile Products manufactured by NECC
Lack of Assurance of Sterility
All Non Sterile Products manufactured by NECC
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
GMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
- Recalling firm
- New England Compounding Center
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-053-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by New England Compounding Center
All 2012 recalls
Class II · Moderate risk
Triamcinolone 10 mg/mL P
Lack of Assurance of Sterility
Class II · Moderate risk
Saline 10% and 3%
Lack of Assurance of Sterility
Class II · Moderate risk
Omnipaque 240mg/mL PF
Lack of Assurance of Sterility
Other cgmp deviation recalls from 2012
All cgmp deviation recalls
Class II · Moderate risk
ABILIFY (aripiprazole)
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Class II · Moderate risk
All Non-Sterile Products manufactured by Ameridose LLC
GMP deficiencies
Class III · Low risk
Lemon Hand Sanitizing Wipes
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Class II · Moderate risk
Orajel Kids My Way! Anticavity Fluoride
CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substituted for PEG.
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