Bleomycin Sulfate Recalled Due to Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all non-expired lots of Bleomycin Sulfate 1unit/ml 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 recall is classified as FDA Class II and involves a lack of sterility assurance in a sterile injectable drug, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all non-expired lots of Bleomycin Sulfate 1unit/ml. The recall is due to concerns regarding quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The recall covers all lots of sterile products compounded by the pharmacy that are not expired. The agency has classified this as a Class II recall. The source text does not specify a distribution region or specific lot numbers, noting only that all lots within expiry are affected.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternatives or disposal.
The recalled product
- Product
- Bleomycin Sulfate 1unit/ml
- 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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