The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0454-2016·Announced 2015-12-09

Western Drug Recalls Super B Comp w/Cyano 3X Inj Due to Sterility Concerns

Western Drug is recalling 15 containers of Super B Comp w/Cyano 3X Inj because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in an injectable) map to a score of 4 (Severe), as they are not Class I but involve significant risk.

Plain-English summary

Western Drug Inc. is recalling 15 containers of Super B Comp w/Cyano 3X Inj, a prescription injectable product. The recall was initiated because the product lacks assurance of sterility. The affected product is distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.

The recall covers all lots of the product. No specific lot numbers are provided in the source text. The product is a prescription item, meaning it is typically dispensed by healthcare providers rather than sold directly to consumers in retail settings.

Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies 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
Super B Comp w/Cyano 3X Inj, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable
Hazard
Affected units
15

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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