The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-307-2016·Announced 2015-11-25

FDA Recalls HCG and Lidocaine Injections Due to Sterility Concerns

Kalman Health & Wellness is recalling HCG 1000 U/LIDO 0.2% Injection vials 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 compounded sterile preparations, which poses a significant risk of infection or serious injury.

Plain-English summary

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is recalling HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in 3 mL and 8 mL vials. The recall is being initiated due to observations associated with poor sterile production practices, which resulted in a lack of sterility assurance for the finished drugs.

The affected products are prescription-only (Rx only) and were distributed nationwide. The recall covers all compounded sterile preparations within their expiry dates. Specific lot numbers identified in the recall are 080415 (Exp 09/04/2015) and 4721-081715 (Exp 09/17/2015).

Consumers and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 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 Preparations
Hazard
Affected units
2

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 (4)

  • Lot #: 080415
  • Exp 09/04/2015
  • and 4721-081715
  • Exp 09/17/2015

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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