Novarel Injection Recalled for Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all non-expired lots of Novarel (IM) due to quality control issues affecting sterility assurance.
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 source text explicitly states the agency classification is Class II. According to the severity rubric, if the agency's own classification is FDA Class I or USDA Class I, the score is never below 4. Since this is FDA Class II, and the rubric maps Class II with potential serious consequences (like sterility failure) to the Severe category (score 4) in the absence of specific hospitalization reports which would push it to Critical, the score is 4.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all non-expired lots of Novarel (IM). The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection.
The recall covers all lots of sterile products compounded by the pharmacy that are not expired. The distribution pattern is listed as NC, and the code information indicates all lot numbers within expiry are affected.
Consumers should check with their healthcare provider or pharmacist regarding the use of this product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Novarel (IM)
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Injectable
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 numbers within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & 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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