Western Drug Recalls Folic Acid Injection Due to Sterility Concerns
Western Drug is recalling Folic Acid Injection due to a lack of assurance of sterility. The product was distributed nationwide in eight states.
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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues in injectable products which carry significant risk.
Plain-English summary
Western Drug Inc. is recalling Folic Acid Injection 5 mg/mL and 10 mg/mL. The recall was initiated because of a lack of assurance of sterility. The affected product is a prescription medication manufactured by Western Drug Inc. in Springerville, Arizona.
The recall involves 8 containers of the product. The distribution pattern indicates the product was shipped nationwide to Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. All lots are affected by this recall.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Folic Acid Injection 5 mg/mL,10 mg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injectable
- Affected units
- 8
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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