Agency classClass IIOur severity:Severe FDA (Drugs)·D-0115-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Procaine MDV Injectable Solution for Sterility Concerns

JD & SN Inc. is recalling Procaine MDV Injectable Solution due to a lack of assurance of sterility. The recall covers 30mL and 300mL containers distributed nationwide.

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, FDA Class II recalls involving significant injury or hospitalization reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in injectable drugs poses a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling Procaine MDV, Injectable Solution, 1%. The affected products are available in 30mL and 300mL container sizes and are prescription-only. The recall is due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.

The recall covers specific lots identified by the codes 06152015@9 and t04022015@17. The distribution pattern for these products is listed as nationwide.

Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: PROCAINE MDV, Injectable Solution,1%, container sizes: 30mL and 300mL, 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

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 (2)

06152015@9
t04022015@17.

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 · sterility