Apothecure Recalls Sterile Compounded Products Due to Sterility Assurance Concerns
Apothecure, Inc. is recalling all lots of sterile compounded products within expiry due to lack of sterility assurance 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. According to the rubric, an FDA Class II recall involving a risk of serious adverse health consequences (lack of sterility assurance in sterile products) corresponds to a severity score of 4 (Severe), particularly given the potential for infection from non-sterile medical products.
Plain-English summary
Apothecure, Inc. is recalling all lots of sterile products compounded by the pharmacy that are within their expiration dates. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
The recall covers all lots of the affected sterile compounded products. The distribution pattern is listed as nationwide. The source text does not specify the exact number of units affected or specific product names beyond the general description of sterile compounded products.
Consumers should check with their healthcare providers or pharmacists regarding the use of these products. The source text does not provide specific instructions for disposal or return, but standard recall procedures generally involve stopping use and contacting the manufacturer or a healthcare professional for guidance.
The recalled product
- Product
- The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
- Manufacturer
- Apothecure, Inc
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 Lots
Distribution
Distributed nationwide across the United States.
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