Vital Rx Recalls Sterile Products Due to Sterility Assurance Concerns
Vital Rx, Inc. is recalling all sterile products due to poor aseptic production practices 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, which corresponds to a Severe severity score under the rubric for significant health risks.
Plain-English summary
Vital Rx, Inc. dba Atlantic Pharmacy and Compounding is recalling all sterile products within their expiry dates. The recall involves 61 products that were distributed nationwide.
The recall was initiated because a recent FDA inspection revealed poor aseptic production practices. These practices resulted in a lack of sterility assurance for the affected products.
Consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- All Sterile Products within expiry
- Hazard
- Affected units
- 61
Distribution
Distributed nationwide across the United States.
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