Agency classClass IIOur severity:Severe FDA (Drugs)·D-0154-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Vitamin D3 Injectable Solution for Sterility Concerns

JD & SN Inc. is recalling 4 syringes of Vitamin D3 Oil Injectable Solution due to a lack of 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 rubric, an FDA Class II recall involving a sterile injectable drug where sterility is not assured is categorized as Severe (Score 4) due to the potential for significant injury or infection.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling four syringes of Vitamin D3 Oil, Injectable Solution, 400,000 UNITS/ML. The product is a prescription-only injectable solution distributed nationwide. The recall is being conducted because of a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.

The specific lot codes associated with this recall are t03032015@1, 04062015@1, 06292015@7, and t04092015@10. 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 firm for further instructions. The recall is limited to the specific syringes and lot codes identified in the notice.

The recalled product

Product: VITAMIN D3 OIL, Injectable Solution, 400,000 UNITS/ML, syringe size: 20 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
Affected units: 4

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 (4)

t03032015@1
04062015@1
06292015@7
t04092015@10

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

See all →

Severe
FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Sodium Tetradecyl Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Six Trimix Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Compounded Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
FDA (Drugs) · 2015-11-04

Same hazard · lack of sterility