Agency classClass IIOur severity:Severe FDA (Drugs)·D-0107-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Methylcobalamin Injectable Solution for Sterility Concerns

JD & SN Inc. is recalling 6 syringes of Methylcobalamin Injectable Solution due to a lack of assurance of sterility. The recall covers all sterile human compounded drugs within their expiry.

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 rubric, an FDA Class II recall involving a sterile injectable drug, where sterility assurance is lacking, falls under the 'Severe' category due to the potential for significant injury or infection.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 6 syringes of Methylcobalamin MDV Injectable Solution, 5 mg/mL, 30 mL. The product is prescription-only and was distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.

The recall applies to all sterile human compounded drugs within their expiry date. The specific code for the affected product is t05282015@23. 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.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm for further instructions. The firm can be reached at (509) 764-2314.

The recalled product

Product: METHYLCOBALAMIN MDV, Injectable Solution, 5 MG/ML, 30 mL syringe, Rx only, JD & SN Inc, DBA Moses Lake Professional Pharmacy, 1555 S. Pilgrim St. Moses Lake WA 98837, (509)764-2314
Manufacturer: JD & SN Inc., dba Moses Lake Professional Pharmacy
Category: Drug — Injectable Solution
Hazard: sterility
infection
Affected units: 6

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)

t05282015@23

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 101 recalled by JD & SN Inc., dba Moses Lake Professional 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 101 products in this recall →

Same manufacturer · JD & SN Inc., dba Moses Lake Professional Pharmacy

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