The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0402-2019·Announced 2019-01-09

Northwest Compounding Pharmacy Recalls Vitamin B12 Liquid Due to Sterility Concerns

Northwest Compounding Pharmacy is recalling Vitamin B12 liquid 1000mcg/ml due to 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. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the text, the agency classification of Class II for a sterile injectable product places it in the Severe category.

Plain-English summary

Hiers Enterprises, LLC dba Northwest Compounding Pharmacy is recalling Vitamin B12 liquid 1000mcg/ml, RX, glass vial (150 ml). The recall was initiated due to a lack of sterility assurance in the product.

The affected product was distributed exclusively in the state of Oregon to three medical facilities, one physician's office, and 80 consumers or patients. The specific lots involved are 10162018@28 (expiration 1/14/19) and 10182018@38 (expiration 1/16/19). Because these are compounded products, labels vary for each patient, and the firm did not provide specific labeling details.

Consumers and healthcare providers who have received this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Vitamin B12 liquid 1000mcg/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 (2)

  • 10162018@28 exp 1/14/19
  • 10182018@38 exp 1/16/19

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 →

Related recalls

Same manufacturer · Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

See all →

Same hazard · lack of sterility

See all →

Similar recalls