Guardian Pharmacy Recalls Phenol 6% Injection Due to Sterility Concerns
Guardian Pharmacy Services is recalling 40 vials of Phenol 6% with Glycerin Injection in Texas due to a lack of sterility assurance.
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 an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
Guardian Pharmacy Services is recalling 40 10-ml vials of Phenol 6% with Glycerin Injection. The product was compounded by Guardian Pharmacy Services and distributed in Texas. The specific lot number is 58913:42, with a use-by date of 06/05/2018.
The recall was initiated because of a lack of sterility assurance. This means the product may not be sterile, which is a critical requirement for injectable medications.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. 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)
- Lots: 58913:42 Use By: 06/05/2018
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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