Ameridose Recalls All Sterile Products Due to Sterility Assurance Concerns
Ameridose LLC is recalling all sterile products manufactured in Westborough, MA, due to a lack of assurance of sterility. The recall is nationwide and includes all lot codes within expiry.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in medical products) are classified as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Ameridose LLC is recalling all sterile products manufactured by the company in Westborough, Massachusetts. The recall is being conducted because of a lack of assurance of sterility for these products. A complete list of the specific products subject to this recall is available online at www.ameridose.com.
The recall covers all lot codes within expiry and is distributed nationwide. The U.S. Food and Drug Administration has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the affected products and refer to the manufacturer's website for the specific list of recalled items. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
- Manufacturer
- Ameridose LLC
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 within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ameridose LLC 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 · Ameridose LLC
See all →- ModerateAmeridose Recalls Non-Sterile Drug Products Due to GMP Deficiencies
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