Agency classClass IIOur severity:Severe FDA (Drugs)·D-0073-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Compounded Injectable Cyanocobalamin Due to Sterility Concerns

Moses Lake Professional Pharmacy is recalling 30 syringes of compounded injectable cyanocobalamin because the product lacks assurance of sterility.

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 defect or significant risk (lack of sterility in injectables) is categorized as Severe (Score 4), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling 30 syringes of CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML. The recall was initiated because the product lacks assurance of sterility. The affected product is a prescription-only compounded drug distributed nationwide.

The recall covers all sterile human compounded drugs within their expiry date. The specific code for the recalled product is t01062015@24. 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 who have this product should stop using it and contact their healthcare provider or the recalling pharmacy for instructions on how to return or dispose of the medication.

The recalled product

Product: CYANOCOBALAMIN MDV (COMPOUNDED), Injectable Solution, 1 MG/ML per 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 — Compounded Injectable
Hazard: lack-of-sterility
infection-risk
Affected units: 30

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)

t01062015@24

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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Same hazard · lack of sterility