The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-300-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections Due to Sterility Concerns

Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromise sterility assurance.

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. The hazard involves a lack of sterility assurance in a sterile injection, which poses a significant risk of serious injury or hospitalization if contaminated, fitting the criteria for a Severe rating.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 35 vials of 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection. The product is a prescription-only medication distributed nationwide. The recall covers specific lots with expiration dates ranging from September 2015 to November 2015.

The recall was initiated due to observations associated with poor sterile production practices. These practices resulted in a lack of assurance of sterility for the finished drugs. The source text does not report any specific illnesses or injuries associated with the use of these products.

Consumers and healthcare providers should stop using the affected vials immediately. Patients should contact their healthcare provider for alternative treatment options. The recall is classified as FDA Class II.

The recalled product

Product
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Manufacturer
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
35

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 (8)

  • Lot #: 060815
  • Exp 09/08/2015
  • 062915
  • Exp 09/29/2015
  • 072315
  • Exp 10/23/2015
  • and 760-081815
  • Exp 11/18/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 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 39 products in this recall →

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