The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-299-2016·Announced 2015-11-25

Essential Wellness Pharma Recalls 17-Alpha Hydroxyprogesterone Injections for Sterility Concerns

Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromised 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 and involves a lack of sterility assurance in a sterile injection, which poses a significant risk of infection and potential hospitalization.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials. The recall covers four vials per unit and includes specific lot numbers 062015, 062215, 062515, and 072115 with expiration dates ranging from September 2015 to October 2015. The product was distributed nationwide.

The recall was initiated because of observations associated with poor sterile production practices. These practices resulted in a lack of sterility assurance for the finished compounded sterile preparations. The agency has classified this recall as Class II.

Consumers and healthcare providers should stop using the affected vials and contact their healthcare provider or the recalling firm for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor 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
4

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 #: 062015
  • Exp 09/20/2015
  • 062215
  • Exp 09/22/2015
  • 062515
  • Exp 09/25/2015
  • and 072115
  • Exp 10/21/2015

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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