Natures Pharmacy Recalls Sterile Compounded Products Due to Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all unexpired lots of sterile compounded products, including Papaverine 12mg/phent 1mg/Pros 9mcq/ml, due to quality control concerns affecting sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 health consequences (such as loss of sterility assurance in sterile products) are rated as Severe (4), as they do not meet the criteria for Critical (Class I) but represent a significant risk.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all lots of sterile products compounded by the pharmacy that are not expired. The recall includes the product Papaverine 12mg/phent 1mg/Pros 9mcq/ml. The recall is limited to products distributed in North Carolina (NC).
The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection. The agency has classified this recall as Class II.
Consumers who possess these products should stop using them and contact the pharmacy or their healthcare provider for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Papaverine 12mg/phent 1mg/Pros 9mcq/ml
- Manufacturer
- Natures Pharmacy & Compounding Center
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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