The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0135-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

JD & SN Inc. is recalling 50 mg testosterone pellets because the FDA cannot ensure the sterile compounded drugs are free from contamination.

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 agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by lack of sterility assurance in compounded drugs) are rated as Severe.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 50 mg testosterone pellets. The recall is being conducted because the U.S. Food and Drug Administration (FDA) has determined that there is a lack of assurance of sterility for these sterile human compounded drugs. The affected products are prescription-only and were distributed nationwide.

The recall covers specific lots of the medication, identified by codes such as t12292014@30 and t11202014@11. The source text indicates that the issue applies to all sterile human compounded drugs within their expiry dates. Consumers and healthcare providers should check their inventory for these specific lot codes.

Individuals who have received these testosterone pellets should contact their healthcare provider for guidance on alternative treatment options. The FDA classifies this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
TESTOSTERONE, Pellet, 50 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
16

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 (16)

  • t12292014@30
  • t11202014@11
  • t10132014@24
  • t09042014@30
  • t08252014@23
  • t06292015@23
  • t06252015@16
  • t06052015@8
  • t05162014@7
  • t05072015@11
  • t04302015@14
  • t03102015@5
  • t03052015@8
  • t03032015@33
  • t02182015@29
  • t01092015@2.

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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