Agency classClass IIOur severity:Severe FDA (Drugs)·D-0090-2016·Announced 2015-11-04

FDA Recalls Compounded Folic Acid Injectable Solution Due to Sterility Concerns

Moses Lake Professional Pharmacy is recalling compounded folic acid injectable solution because the agency cannot assure 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, which corresponds to a Severe rating (Score 4) under the rubric, particularly given the risk of infection associated with non-sterile injectable drugs.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for compounded folic acid injectable solution manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The product is a prescription-only, 5 mg/mL solution packaged in 5 mL syringes. The recall involves 3 syringes with the code t06032015@23.

The recall was initiated due to a lack of assurance of sterility. The FDA notes that all sterile human compounded drugs within their expiry date are affected by this concern. The distribution pattern for this product is listed as nationwide.

Consumers and healthcare providers should stop using the affected folic acid injectable solution and contact their pharmacist or the recalling firm, Moses Lake Professional Pharmacy, for further instructions on how to return or dispose of the product.

The recalled product

Product: FOLIC ACID (COMPOUNDED), Injectable Solution, 5 mg/mL, 5 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 — Compounded Injectable
Hazard: lack-of-sterility
infection-risk
Affected units: 3

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)

t06032015@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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