Western Drug Recalls M-Cobalamin 2/Folate Injection Due to Sterility Concerns
Western Drug is recalling M-Cobalamin 2/Folate 5mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.
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, FDA Class II recalls involving significant injury or property damage reports, or in this case a critical sterility failure in an injectable drug, are classified as Severe (Score 4).
Plain-English summary
Western Drug Inc. is recalling M-Cobalamin 2/Folate 5mg/mL Injection, a prescription medication. The recall was initiated because the product lacks assurance of sterility. The affected product is distributed in 2 containers.
The recall covers all lots of the product. Distribution was nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- M-Cobalamin 2/Folate 5mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injection
- Hazard
- Affected units
- 2
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)
- all lots
Distribution
Part of a larger recall action
This product is one of 91 recalled by Western Drug 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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