The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0064-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Chorionic Gonadotropin Due to Sterility Concerns

JD & SN Inc. is recalling specific vials of Chorionic Gonadotropin because the FDA cannot assure the sterility of the compounded drug.

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 identifies the recall as FDA Class II. According to the severity rubric, an FDA Class II recall with potential for adverse health consequences (lack of sterility assurance) corresponds to a score of 4 (Severe), as it is not Class I but involves a significant risk factor.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling specific vials of Chorionic Gonadotropin, Injectable Solution. The recall involves 44 vials of various sizes, including 4 mL, 5 mL, 6 mL, 7.5 mL, 9 mL, 10 mL, 12 mL, 15 mL, 20 mL, and 28 mL containers. The product is prescription-only and was distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The FDA has determined that it cannot guarantee that all sterile human compounded drugs within their expiration dates are sterile. This classification is designated as FDA Class II, which indicates a situation where 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.

Patients who have received this medication should contact their healthcare provider for further instructions. The recall is limited to the specific lot codes and quantities listed in the official FDA notice. Consumers should not use the remaining vials until they have consulted with a medical professional.

The recalled product

Product
CHORIONIC GONADOTROPIN, Injectable Solution, 200 UNITS/0.1 ML, vial sizes: 4 mL; 5 mL; 6 mL; 7.5 mL ; 9 mL, 10 mL; 12 mL; 15 mL; 20 mL; 28 mL; 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 (20)

  • 11032014@10
  • 12082014@3
  • t01082015@26
  • t03092015@26
  • t03132015@13
  • t03162015@12
  • t03242015@19
  • t04092015@21
  • t05132015@28
  • t05132015@44
  • t05202015@22
  • t05262015@14
  • t05272015@36
  • t06172015@27
  • t06182015@7
  • t06242015@9
  • t06292015@11
  • t07092015@42
  • t07102015@25
  • t08012014@1

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

See all →

Same hazard · sterility

See all →

Similar recalls