Guardian Pharmacy Recalls Methylene Blue Syringes Due to Sterility Concerns
Guardian Pharmacy Services is recalling 95 vials of Methylene Blue 10 mg/mL in 1 mL syringes due to a lack of sterility assurance. The product was distributed in Texas.
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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance) are categorized as Severe.
Plain-English summary
Guardian Pharmacy Services is recalling 95 1-mL syringes of Methylene Blue 10 mg/mL. The recall was initiated because of a lack of sterility assurance for the compounded product. The affected lots are 59185:42 (Use By: 07/30/2018), 58471:42 (Use By: 05/27/2018), and 58745:42 (Use By: 06/10/2018).
The product was distributed in Texas. The FDA has classified this recall as Class II, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the recalled product and contact Guardian Pharmacy Services for further instructions or a refund.
The recalled product
- Product
- Methylene Blue 10 mg/mL 1ml. Packaged in 1 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 (3)
- Lots: 59185:42 Use By: 07/30/2018
- 58471:42 Use By: 05/27/2018
- 58745:42 Use By: 06/10/2018
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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