Prostaglandin Compounded Sterile Products Recalled for Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all non-expired lots of compounded sterile prostaglandin products due to quality control concerns identified during an FDA inspection.
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 and involves a potential risk to sterility assurance in sterile products, which aligns with the 'Severe' criteria for significant injury risk or Class II classifications with potential for serious harm.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all non-expired lots of sterile prostaglandin products in all combinations. The recall was initiated 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 lot numbers within the expiration date for these sterile products. The distribution is limited to North Carolina (NC). No specific illness or injury reports are mentioned in the source text.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Prostaglandin all combinations
- 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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