Recalls / Class II

Class IID-311-2016

Product

HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Affected lot / code info

Lot #: 080615, Exp 09/06/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/14/2015; 1730-081715, Exp 09/17/2015; 1730-081815, Exp 09/18/2015; and 1730-081915, Exp 09/19/2015

Why it was 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.

Recalling firm

Firm

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

4625 N University St, N/A, Peoria, Illinois 61614-5828

Distribution

Quantity

21 vials and 80 prefilled syringes

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-09-03

FDA classified

2015-11-17

Posted by FDA

2015-11-25

Terminated

2017-12-29

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-311-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.