New England Compounding Center Recalls Non-Sterile Products Due to GMP Deviations
New England Compounding Center is voluntarily recalling all non-sterile products due to Good Manufacturing Practice (GMP) deviations. The recall covers products distributed nationwide and in Japan.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for serious injury or hospitalization are rated as Severe (4).
Plain-English summary
New England Compounding Center (NECC) is voluntarily recalling all non-sterile products manufactured by the company in Framingham, Massachusetts. The recall was initiated on October 6, 2012, and was classified as Class II by the FDA. The reason for the recall is cited as Good Manufacturing Practice (GMP) deviations.
The affected products include all non-sterile items produced by NECC, with a complete list available on the company's website. The distribution pattern for these products was nationwide in the United States and in Japan. All lot codes are included in this recall.
Consumers who have purchased these products should check the NECC website for the specific list of affected items. The recall was initiated by the firm and was terminated on October 7, 2016.
The recalled product
- Product
- 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
- Manufacturer
- New England Compounding Center
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by New England Compounding Center under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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