The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0086-2016·Announced 2015-11-04

FDA Recalls Estradiol Pellets Due to Sterility Assurance Concerns

The FDA is recalling Estradiol Pellets, 6 mg, compounded by JD & SN Inc. because the agency cannot assure the sterility of the product.

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. According to the rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility assurance for a sterile drug) is categorized as Severe (Score 4), as it is not explicitly Class I but involves a serious potential hazard.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Estradiol Pellets, 6 mg, compounded by JD & SN Inc., dba Moses Lake Professional Pharmacy. The recall was initiated because the agency lacks assurance of the sterility of the product. The affected product is a prescription-only medication consisting of 79 pellets per unit.

The recall covers all sterile human compounded drugs within their expiration dates. The distribution pattern for the affected units is listed as nationwide. Specific lot codes associated with the recall include t12242014@13, t12092014@20, t11172014@26, t10032014@20, t09162014@19, t08152014@8, t07232014@21, t06122015@14, t05222015@11, t04092015@5, t02252015@11, and t01122015@34.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on next steps. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ESTRADIOL, Pellet, 6 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
Affected units
79

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 (12)

  • t12242014@13
  • t12092014@20
  • t11172014@26
  • t10032014@20
  • t09162014@19
  • t08152014@8
  • t07232014@21
  • t06122015@14
  • t05222015@11
  • t04092015@5
  • t02252015@11
  • t01122015@34.

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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