The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0100-2016·Announced 2015-11-04

Moses Lake Pharmacy Recalls Hydroxyprogesterone Caproate Oil Due to Sterility Concerns

JD & SN Inc. is recalling specific syringes of Hydroxyprogesterone Caproate Oil 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 recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

JD & SN Inc., doing business as Moses Lake Professional Pharmacy, is recalling specific syringes of Hydroxyprogesterone Caproate Oil, injectable Solution, 250 mg/mL. The recall covers various syringe sizes, including 4 mL, 5 mL, 6 mL, 10 mL, 16 mL, 18 mL, 20 mL, and 22 mL. The affected products were 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 free from contamination. This classification is designated as FDA Class II.

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 documentation.

The recalled product

Product
HYDROXYPROGESTERONE CAPROATE OIL, injectable Solution, 250 mg/mL, syringe sizes: 4 mL; 5 mL; 6 mL; 10 mL; 16 mL; 18 mL; 20 mL; and 22 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 — Injectable Solution
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)

  • t12182014@7
  • t12052014@12
  • t10312014@21
  • t10102014@21
  • t10072014@6
  • t09172014@30
  • t09152014@11
  • t08132014@13
  • t08112014@28
  • t07282014@28
  • t07282014@16
  • t07012015@7
  • t06302015@31
  • t06222015@17
  • t06112015@14
  • t06022015@17
  • t05182015@24
  • t05152015@19
  • t05072015@9
  • t04272015@19

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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