The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0141-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Compounded Testosterone Cypionate Injectable Solution

Moses Lake Professional Pharmacy is recalling compounded Testosterone Cypionate injectable solution due to a lack of assurance of sterility.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no injuries are reported, the lack of sterility assurance in an injectable drug represents a significant risk of serious harm (sepsis, infection), fitting the 'Severe' criteria for high-risk products where injury has not yet been reported but the potential for serious harm is high.

Plain-English summary

JD & SN Inc., dba Moses Lake Professional Pharmacy, is recalling specific lots of compounded Testosterone Cypionate Injectable Solution, 200 MG/ML. The affected product is available in 5mL and 10mL syringes and is prescription-only. The recall involves 38 10mL syringes and 7 5mL syringes.

The recall was initiated because of a lack of assurance of sterility for all sterile human compounded drugs within their expiry dates. The source text does not specify the exact nature of the sterility failure or the specific pathogens involved.

The affected product was distributed nationwide. Consumers who have this product should contact their healthcare provider or the pharmacy for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
TESTOSTERONE CYPIONATE (COMPOUNDED), Injectable Solution, 200 MG/ML, syringe sizes: 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 — Compounded Injectable
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 (13)

  • t12232014@27
  • t11112014@12
  • t08072014@38
  • t07142015@22
  • t07102015@26
  • t06232014@25
  • t06042015@24
  • 06172015@13
  • 04202015@7
  • 03092015@11
  • 02022015@3
  • 01192015@8
  • 01052015@10.

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 · lack of sterility

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