Agency classClass IIOur severity:Severe FDA (Drugs)·D-0091-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Folic Acid Injectable Solution Due to Sterility Concerns

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling six syringes of Folic Acid Injectable Solution because the sterility of the compounded drug cannot be assured.

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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or death if administered.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling six syringes of Folic Acid, Injectable Solution, 10 mg/mL, 30 mL syringe. The recall was initiated because the company cannot assure the sterility of the sterile human compounded drugs within their expiry dates.

The affected product is prescription-only and was distributed nationwide. The recall covers specific lots identified by the codes t02182015@36, t03052015@23, t03302015@17, t05132015@33, and t06192015@20.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: FOLIC ACID, Injectable Solution, 10 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 (5)

t02182015@36
t03052015@23
t03302015@17
t05132015@33
t06192015@20

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 · sterility