Papaverine Injection Recalled for Lack of Sterility Assurance
Natures Pharmacy & Compounding Center is recalling Papaverine 1nj 30mg/ml due to quality control concerns that present a potential risk to 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 identifies a lack of sterility assurance in a sterile injectable product, which presents a significant risk of serious injury or death from infection, meeting the criteria for a Severe (Score 4) classification.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all lots of Papaverine 1nj 30mg/ml that are not expired. The recall is due to concerns associated with quality control procedures that present a potential risk to sterility assurance.
These quality control concerns were observed during a recent FDA inspection. The agency has classified this recall as Class II.
The recall applies to all lots of sterile products compounded by the pharmacy that are not expired. Consumers should contact their healthcare provider or the pharmacy for further instructions regarding the use of these products.
The recalled product
- Product
- Papaverine 1nj 30mg/ml
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Injectable
- 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 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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