Agency classClass IIOur severity:Severe FDA (Drugs)·D-0109-2016·Announced 2015-11-04

FDA Recalls Methylcobalamin Injectable Syringes Due to Sterility Concerns

The FDA is recalling 36 syringes of Methylcobalamin Injectable Solution because the manufacturer cannot ensure the product is sterile.

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, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility in an injectable drug) corresponds to a severity score of 4 (Severe), as it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Methylcobalamin Preservative Free Prefilled Injectable Solution, 1 mg/mL. The recall involves 36 syringes manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The product is distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within the expiry date are affected by this issue. The specific code for the recalled items is t07142015@46.

Consumers and healthcare providers should stop using the recalled product immediately. Patients who have received this medication should contact their healthcare provider for further instructions. The recall is classified as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: METHYLCOBALAMIN PRESERVATIVE FREE PREFILLED, Injectable Solution,1 mg/mL, 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: lack-of-sterility
infection-risk
Affected units: 36

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)

t07142015@46

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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