Guardian Pharmacy Recalls EDTA Disodium Syringes for Sterility Concerns
Guardian Pharmacy Services is recalling EDTA Disodium 30 mg/mL pre-filled syringes due to a lack of sterility assurance. The product was distributed in Texas.
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 pre-filled syringe, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Guardian Pharmacy Services is recalling EDTA Disodium 30 mg/mL pre-filled syringes, packaged in 1 mL units. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product is identified by Lot 58897:42 and has a use-by date of 07/04/2018. The recall is classified as Class II by the U.S. Food and Drug Administration. The product was distributed in Texas.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Manufacturer
- Guardian Pharmacy Services
- Category
- Drug — Compounded Injectable
- Hazard
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: 58897:42 Use By: 07/04/2018
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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