Guardian Pharmacy Recalls Methylcobalamin Vials Due to Sterility Concerns
Guardian Pharmacy Services is recalling 2,000 vials of compounded Methylcobalamin 1000 mcg/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 severity rubric, FDA Class II recalls with potential for hospitalization or significant injury are rated as Severe (4).
Plain-English summary
Guardian Pharmacy Services is recalling 2,000 100-milliliter vials of compounded Methylcobalamin 1000 mcg/mL. The product is prescription-only and was distributed in Texas. The recall is being conducted due to a lack of sterility assurance.
The affected lots are 58409:42 (Use By: 05/21/2018), 58899:42 (Use By: 07/04/2018), and 59215:42 (Use By: 08/01/2018). The product was packaged in 100ml MDV vials and compounded by Guardian Pharmacy Services located in Dallas, Texas.
Patients who have received this medication should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV 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 (5)
- Lots: 58409:42
- Use By: 05/21/2018
- 58899:42
- Use By: 07/04/2018
- 59215:42 Use By: 08/01/2018
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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