The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0399-2019·Announced 2019-01-09

Northwest Compounding Pharmacy Recalls MIC B Vitamin Liquid for Sterility Concerns

Northwest Compounding Pharmacy is recalling MIC B vitamin liquid due to a lack of sterility assurance. The product was distributed in Oregon to medical facilities and patients.

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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in injectable/liquid medications) are categorized as Severe (Score 4), as they are not Class I (Critical) but represent a significant risk.

Plain-English summary

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vials. The recall is being conducted because of a lack of sterility assurance in the product.

The affected product was distributed exclusively in the state of Oregon. Distribution included 3 medical facilities, 1 physician's office, and 80 consumers or patients. The product is a compounded medication, meaning labels vary for each specific patient compound, and the firm did not provide specific labeling details for the recall notice.

Consumers and medical facilities should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
Manufacturer
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Category
Drug — Compounded Medication
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 (3)

  • 1) 10192018@8 exp 2/28/19
  • MIC Ba w/ aminos 2) 10292018@15 exp 1/31/19
  • MIC B

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 17 recalled by Hiers Enterprises, LLC dba Northwest Compounding Pharmacy 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 17 products in this recall →

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