The Recall Desk
SevereFDA (Drugs)·D-0143-2016·Announced 2015-11-04

FDA Recalls Testosterone Cypionate Injection Due to Sterility Concerns

FDA is recalling Testosterone Cypionate for SubQ Injection from Moses Lake Professional Pharmacy due to lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Testosterone Cypionate for SubQ Injection, an injectable solution (200 mg/mL) available in 5mL and 10mL syringes. The product is manufactured by JD & SN Inc., dba Moses Lake Professional Pharmacy, located in Moses Lake, Washington. The recall involves 243 10mL syringes and 5 5mL syringes that were distributed nationwide.

The reason for the recall is a lack of assurance of sterility. The FDA notes that all sterile human compounded drugs within their expiry date are affected by this issue. This classification indicates a potential risk that the product may not be sterile, which is a critical safety requirement for injectable medications.

Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments or next steps.

The recalled product

Product
TESTOSTERONE CYPIONATE FOR SUBQ INJECTION, Injectable Solution, 200 mg/mL, syringe size: 5ml and 10mL, 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 Sterile Compounded Drug
Hazard

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)

  • t12312014@11
  • t10302014@9
  • t08062014@28
  • t05292015@30
  • t04282015@12
  • t04092015@22
  • t03302015@1
  • t03102015@29
  • t02172015@2
  • t01292015@18
  • 12082014@10
  • 11242014@5
  • 11122014@5
  • 10222014@24
  • 10012014@19
  • 09242014@7
  • 09152014@17
  • 08152014@27
  • 08042014@6
  • 07112014@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 →

Related recalls

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

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Same hazard · sterility failure

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