Agency classClass IIOur severity:Severe FDA (Drugs)·D-1476-2019·Announced 2019-07-17

Hydroxocobalamin Injection Recalled for Lack of Sterility Assurance

First Pharma Associates is recalling Hydroxocobalamin 10 mg/mL Injection due to a lack of assurance of sterility. The product is distributed in Idaho and Washington.

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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a structural or sterility defect in a drug product is categorized as Severe (Score 4), as it carries a risk of adverse health consequences even if serious injury is not explicitly reported in the source text.

Plain-English summary

First Pharma Associates LLC dba Riverpoint Pharmacy is recalling Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vials. The recall is being conducted because of a lack of assurance of sterility. The affected product is prescription-only and was distributed in Idaho and Washington.

The specific lots involved are identified by Lot # 05282019@53 with expiration dates of 08/26/2019 and 08/28/2019. The total quantity involved is 60 mL. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. Patients should consult their healthcare provider regarding alternative treatments if necessary.

The recalled product

Product: Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Manufacturer: First Pharma Associates LLC dba Riverpoint Pharmacy
Category: Drug — Injectable
Hazard: sterility

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)

Lot #: 05282019@53
Exp. 08/26/2019 and Exp. 08/28/2019

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 18 recalled by First Pharma Associates LLC dba Riverpoint 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 18 products in this recall →

Same manufacturer · First Pharma Associates LLC dba Riverpoint Pharmacy

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Same hazard · sterility