Home / Recalls / Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / D-330-2016

D-330-2016 Class II Terminated

Recalled by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma — Peoria, IL

FDA drug recall D-330-2016 was initiated by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma on September 3, 2015 and is designated Class II. Reason for recall: 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 l… The recall status is terminated (terminated December 29, 2017). Affected quantity: 20 vials.

Recall Details

Product Type
Drugs
Report Date
November 25, 2015
Initiation Date
September 3, 2015
Termination Date
December 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 vials

Product Description

Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

Lot #: 062915, Exp 09/29/2015; and 071615, Exp 10/16/2015

Other recalls by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

  • D-310-2016 Class II — HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, (September 3, 2015)
  • D-325-2016 Class II — Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, (September 3, 2015)
  • D-306-2016 Class II — HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) (September 3, 2015)
  • D-332-2016 Class II — TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. (September 3, 2015)
  • D-308-2016 Class II — HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Es (September 3, 2015)
  • D-307-2016 Class II — HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx on (September 3, 2015)
  • D-314-2016 Class II — Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, (September 3, 2015)
  • D-304-2016 Class II — DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL via (September 3, 2015)
  • D-326-2016 Class II — sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wel (September 3, 2015)
  • D-321-2016 Class II — Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wel (September 3, 2015)

FDA data resources