The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0132-2016·Announced 2015-11-04

FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns

Moses Lake Professional Pharmacy is recalling 355 testosterone pellets because the FDA cannot assure they are sterile. Patients should stop using the product and consult a healthcare provider.

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 source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls with potential for hospitalization or significant injury are classified as Severe (Score 4). While no specific injuries are reported in the text, the agency's classification mandates a minimum score of 4.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 355 units of Testosterone, Pellet, 125 mg, manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall was initiated due to a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates.

The affected product is a prescription-only medication distributed nationwide. The recall covers specific lots identified by codes ranging from 01052015@21 to t06272014@20. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health problems, or where the probability of serious adverse health consequences is remote.

Patients who have received this product should stop using it immediately and consult their healthcare provider for further instructions. The recalling firm is responsible for managing the recall and ensuring the product is removed from distribution.

The recalled product

Product
TESTOSTERONE, Pellet, 125 mg, 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 Sterile Drug
Hazard
Affected units
355

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)

  • 01052015@21
  • 01162015@21
  • 02122015@8
  • 03252015@14
  • 04022015@14
  • 04102015@8
  • 04172015@30
  • 05192015@8
  • 06162014@12
  • 07102015@6
  • 07222014@18
  • 08072014@3
  • 08192014@5
  • 09022014@36
  • 09102014@26
  • 09192014@19
  • 10032014@25
  • 10092014@11
  • 10282014@1
  • 10312014@8

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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Same hazard · sterility failure

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