FDAClass IINovember 25, 2015

sermorelin 1000 mcg/mL / LIDO 0.2% Injection recall: Sterility Concern

sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Why was sermorelin 1000 mcg/mL / LIDO 0.2% Injection recalled?

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 080415, Exp 09/04/2015

Product
sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Recalling firm
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Quantity
2 vials
Distribution
Nationwide
Recall date
November 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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