Guardian Pharmacy Recalls Cefazolin Syringes Due to Sterility Concerns
Guardian Pharmacy Services is recalling Cefazolin 2 Gm/20 mL syringes 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in a compounded injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Guardian Pharmacy Services is recalling 60 20-mL syringes of Cefazolin 2 Gm/20 mL. The product is compounded by Guardian Pharmacy Services, located in Dallas, Texas, and was distributed in Texas. The recall is being conducted because of a lack of sterility assurance.
The affected lots are 58758, 58760, 58756, 59095:42, 59093:42, and 59091:42. The source text does not specify the number of units affected or report any illnesses or injuries. Consumers should stop using the product and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. 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 (6)
- Lot: 58758
- 58760
- 58756
- 59095:42
- 59093:42
- 59091:42
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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