Assurance Infusion Recalls LIPO B Syringes and Vials for Sterility Concerns
Assurance Infusion is recalling LIPO B 25MG/50MG/50MG/1000MCG/ML products due to a lack of sterility assurance. The recall covers nationwide distribution.
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 a medical product, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Assurance Infusion is recalling LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial. The recall is being conducted due to a lack of sterility assurance. The affected product quantity is 2 syringes/1 vial.
The recall covers products distributed nationwide within the United States. The specific lot number is 09172019@18 with an expiration date of 03/15/2020. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact Assurance Infusion at (713) 533-8800 for further instructions.
The recalled product
- Product
- LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800
- Manufacturer
- Assurance Infusion
- Category
- Drug — Injectable Medication
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)
- Lot: 09172019@18 Exp. 03/15/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Assurance Infusion 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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