Guardian Pharmacy Recalls Glycopyrrolate Syringes Due to Sterility Concerns
Guardian Pharmacy Services is recalling 100 syringes of compounded Glycopyrrolate 0.2 mg/mL 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. According to the rubric, an FDA Class II recall involving a significant injury risk (lack of sterility assurance) corresponds to a severity score of 4 (Severe).
Plain-English summary
Guardian Pharmacy Services is recalling 100 2-mL syringes of compounded Glycopyrrolate 0.2 mg/mL. The product is prescription-only and was distributed in Texas. The specific lot number is 58811:93, with a use-by date of 06/18/2018.
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 to patients.
Patients who have received this medication should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 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 (1)
- Lot: 58811:93 Use By: 06/18/2018
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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