Agency classClass IIOur severity:Severe FDA (Drugs)·D-0138-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

JD & SN Inc. is recalling 18-pellet vials of 76 mg Testosterone Pellets because the FDA determined there is 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 recall is classified as FDA Class II and involves a lack of assurance of sterility, which is a significant safety hazard for a sterile compounded drug.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling 18-pellet vials of 76 mg Testosterone Pellets. The recall was initiated because the U.S. Food and Drug Administration determined there is a lack of assurance of sterility for the product. The agency classification for this recall is Class II.

The affected product is a prescription-only compounded drug. The recall covers specific lots identified by the codes t12172014@7, t12092014@16, t10062014@26, t08252014@4, t05292015@3, t05212015@18, t05052014@11, t04012015@1, t01202015@15, and t01052015@30. The distribution pattern for these products is listed as nationwide.

Consumers who have this product should contact their healthcare provider or the recalling firm, JD & SN Inc., for instructions on how to return the product or obtain a replacement. The firm can be reached at (509) 764-2314.

The recalled product

Product: TESTOSTERONE, Pellet, 76 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: sterility
Affected units: 18

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 (10)

t12172014@7
t12092014@16
t10062014@26
t08252014@4
t05292015@3
t05212015@18
t05052014@11
t04012015@1
t01202015@15
t01052015@30.

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 →

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

See all →

Severe
FDA Recalls Estradiol Pellets Due to Lack of Sterility Assurance
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Sodium Tetradecyl Sulfate Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Six Trimix Syringes Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
Moses Lake Pharmacy Recalls Compounded Chorionic Gonadotropin Due to Sterility Concerns
FDA (Drugs) · 2015-11-04
Severe
FDA Recalls Compounded Progesterone Pellets Due to Sterility Concerns
FDA (Drugs) · 2015-11-04

Same hazard · sterility