The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0057-2016·Announced 2015-11-04

FDA Recalls Alprostadil/Procaine Injectable Solution Due to Sterility Concerns

The FDA is recalling 27 vials of Alprostadil/Procaine 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, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While the source does not explicitly list hospitalizations, the lack of sterility assurance in an injectable drug presents a significant risk of serious harm, aligning with the Severe classification for high-risk pharmaceutical defects.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Alprostadil/Procaine, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials. The recall is being conducted by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The agency has classified this as a Class II recall.

The reason for the recall is a lack of assurance of sterility. The source text indicates that all sterile human compounded drugs within the expiry date are affected. A total of 27 vials are involved in this recall. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should stop using the affected vials immediately. The specific lot codes associated with this recall include t01212015@26, t01292015@12, t02062015@28, t02092015@14, t02182015@37, t03112015@21, t03302015@3, t05182015@26, t06012015@9, t06042015@31, t06102015@29, t06222015@36, t07062015@4, t07312014@30, t08052014@19, t10082014@18, t10132014@8, t10142014@11, t10232014@23, t11072014@7, t11112014@24, t11182014@13, t12152014@15, and t12162014@7. Individuals with questions should contact the recalling firm at (509) 764-2314.

The recalled product

Product
ALPROSTADIL/PROCAINE, Injectable Solution, 40 MCG/0.1%/ML, 10 mL and 20 mL vials, 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
Affected units
27

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 (20)

  • t01212015@26
  • t01292015@12
  • t02062015@28
  • t02092015@14
  • t02182015@37
  • t03112015@21
  • t03302015@3
  • t05182015@26
  • t06012015@9
  • t06042015@31
  • t06102015@29
  • t06222015@36
  • t07062015@4
  • t07312014@30
  • t08052014@19
  • t10082014@18
  • t10132014@8
  • t10142014@11
  • t10232014@23
  • t11072014@7

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 →

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Same manufacturer · JD & SN Inc., dba Moses Lake Professional Pharmacy

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