Guardian Pharmacy Recalls Hyaluronidase Vials Due to Sterility Concerns
Guardian Pharmacy Services is recalling Hyaluronidase 150 units/mL vials in Texas due to a lack of sterility assurance.
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 the hazard involves a lack of sterility assurance in a compounded drug, which carries a significant risk of serious injury or infection.
Plain-English summary
Guardian Pharmacy Services is recalling 2 1-ml vials of Hyaluronidase 150 units/mL. The product is prescription-only and was distributed in Texas. The specific lot number is 58895:42, with a use-by date of 06/27/2018.
The recall was initiated because of a lack of sterility assurance. This means the product may not be sterile, which poses a risk of infection if administered.
Consumers and healthcare providers who have this specific lot of Hyaluronidase should stop using it immediately. They should contact their pharmacist or Guardian Pharmacy Services for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
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: 58895:42 Use By: 06/27/2018
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 23 recalled by Guardian Pharmacy Services 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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