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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
See all 2 products in this recall →Related recalls
Same manufacturer · New England Compounding Center
See all →- SevereNew England Compounding Center Recalls Lidocaine Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereNew England Compounding Center Recalls Isovue Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereNew England Compounding Center Recalls Lidocaine Dextrose Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- HighNew England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- CriticalFDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
FDA (Drugs) · 2013-01-09
Same hazard · gmp deviations
See all →- ModerateMilbar Recalls DCL T Shampoo for GMP Deviations
FDA (Drugs) · 2020-11-25
- ModerateMilbar Recalls Solar Defense Sunscreen Due to GMP Deviations
FDA (Drugs) · 2018-05-23
- SeverePhillips Co. Recalls StingMed Insect Bites Skin Protectant Due to GMP Deviations
FDA (Drugs) · 2017-07-12
- SeverePhillips Recalls Diabecline Topical Ointment Due to Manufacturing Deviations
FDA (Drugs) · 2017-07-12
Similar recalls
- SevereNew England Compounding Center Recalls Bupivacaine Products Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereNew England Compounding Center Recalls Glycerin 100% Vials for Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereNew England Compounding Center Recalls Lidocaine Dextrose Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- ModerateAmeridose Recalls Non-Sterile Drug Products Due to GMP Deficiencies
FDA (Drugs) · 2012-11-21
- HighNew England Compounding Center Recalls Omnipaque Vials Due to Sterility Concerns
FDA (Drugs) · 2013-01-09
- SevereNew England Compounding Center Recalls Betamethasone Repository Injections
FDA (Drugs) · 2013-01-09