The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0404-2016·Announced 2015-12-09

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard
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

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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.

See all 91 products in this recall →

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