FDA Recalls Estradiol and Testosterone Compounds for Sterility Concerns
Natures Pharmacy & Compounding Center is recalling all lots of Estradiol Cypionate and Testosterone Cypionate due to sterility assurance concerns identified during an FDA inspection.
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 sterile compounded products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol Cypionate 2mg/cc and Testosterone Cypionate 50mg compounded by Natures Pharmacy & Compounding Center. The recall covers all lots of these sterile products that are not expired.
The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility of the compounded products. The agency classifies this recall as Class II.
Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions. The recall is limited to North Carolina (NC).
The recalled product
- Product
- Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg
- 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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