Unique Pharmaceutical Recalls Sterile Products Due to Sterility Assurance Issues
Unique Pharmaceutical, Ltd is recalling all sterile products due to poor aseptic production practices identified by 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 the hazard involves a lack of sterility assurance in sterile products, which poses a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Unique Pharmaceutical, Ltd is voluntarily recalling all sterile products within their expiry dates. The recall involves 325,225 units, including syringes, vials, and bags, distributed nationwide.
The recall was initiated after a recent FDA inspection revealed poor aseptic production practices. These practices resulted in a lack of sterility assurance for products intended to be sterile. The recall covers all lots of the affected products.
Consumers and healthcare providers should stop using these products and contact the manufacturer or their supplier for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- All sterile products within expiry
- Manufacturer
- Unique Pharmaceutical, Ltd
- Category
- Drug — Sterile Products
- Affected units
- 325,225
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.
Part of a larger recall action
This product is one of 2 recalled by Unique Pharmaceutical, Ltd 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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