Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs Due to a Potential Lack of Sterility Assurance

Summary

Company Announcement Date:: May 23, 2019
FDA Publish Date:: May 24, 2019
Reason for Announcement:
Company Name:: Pharm D Solutions, LLC
Brand Name:: Pharm D Solutions
Product Description:: Sterile Compounded Drug Products

Company Announcement

FOR IMMEDIATE RELEASE – Houston, Texas, Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.

The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within from October 24, 2018 to May 21,2019. The sterile drug products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The recall does not affect the pharmacy's non-sterile compounded products or retail pharmacy operations.

The pharmacy has notified potentially affected customers of the voluntary recall via U.S. Mail and direct outreach. Customers who have received sterile compounded products subject to the voluntary recall should stop using and return the product to the pharmacy for a full refund.

Consumers with questions regarding this recall can contact Pharm D Solutions, LLC by calling Luis R DeLeon or Carlos DeLeon at 1-844-263-6846, Monday through Friday between 10:00 a.m. and 4:30 p.m., CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

PRODUCT	LOT NUMBER
TESTOSTERONE CYPIONATE GS 200 MG/ML 10 ML	10242018:70/A
TESTOSTERONE 200 MG/ML GRAPESEED OIL 30 ML 200 MG/ML	10242018:70/B
HUMAN CHORIONIC GONADOTROPIN 3000 IU LYOPHILIZED	10292018:21
TESTOSTERONE 200 MG/ML GRAPESEED OIL 30 ML 200 MG/ML	10302018:63/A
TESTOSTERONE CYPIONATE GS 200 MG/ML 5 ML	10242018:70/P
BACTERIOSTATIC WATER FOR INJECTION 10 ML	11292018:75
SERMORELIN/GHRP-2/GHRP-6 3 MG/3 MG/3 MG LYOPHILIZED	12062018:17
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	12262018:69
BACTERIOSTATIC WATER FOR INJECTION 10 ML 10 ML	01022019:70
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	01072019:12
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	01072019:88
HUMAN CHORIONIC GONADOTROPIN 5000 IU LYOPHILIZED	01082019:88
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	01172019:69
HUMAN CHORIONIC GONADOTROPIN 12000 IU LYOPHILIZED	01232019:86
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	01252019:94
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	01282019:55
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	01292019:69
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	01312019:86
TESTOSTERONE CYP/PRO 200 MG/10 MG /ML 10 ML INJECTABLE	01312019:02
NANDROLONE GS 10 ML 200 MG/ML INJECTABLE	01312019:34
BACTERIOSTATIC WATER FOR INJECTION 10 ML 10 ML INJECTABLE	02042019:04
HUMAN CHOIONIC GONADOTROPIN 10,000 IU LYOPHILIZED	02052019:42
TESTOSTERONE CYP/PRO 200 MG/10 MG /ML 10 ML INJECTABLE	02072019:45/A
SERMORELIN/GHRP-2/GHRP-6 9 MG/9 MG/9 MG LYOPHILIZED	02182019:79
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	02202019:53/A
TESTOSTERONE CYPIONATE GS 200 MG/ML 10 ML INJECTABLE	02262019:49/A
BACTERIOSTATIC WATER FOR INJECTION 10 ML 10 ML INJECTABLE	03042019:94
SERMORELIN/GHRP-2 9 MG-6 MG LYOPHILIZED	03052019:43
HUMAN CHORIONIC GONADOTROPIN 5000 IU LYOPHILIZED	03182019:58
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	04012019:67/A
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	04022019:47/A
B-COMPLEX B-1,B-6,B-3,B-12,B-5 100,2.54 INJECTABLE 10 ml	04032019:23
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	04042019:04/A
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	04042019:61
SERMORELIN/GHRP-2 9 MG-6 MG LYOPHILIZED	04042019:15
HUMAN CHORIONIC GONADOTROPIN 12000 IU LYOPHILIZED	04042019:86
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	04082019:38/A
SERMORELIN/GHRP-2/GHRP-6 9 MG/9 MG/9 MG LYOPHILIZED	04162019:86
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	04162019:48
SERMORELIN/GHRP-2 9 MG-6 MG LYOPHILIZED	04172019:08
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	04302019:49/A
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	04302019:70
IPAMORELIN ACETATE 9 MG INJECTABLE	05022019:50
TRIMIX PAPAVERINE/PHENTOLAMINE/ALPROSTADIL 30 MG / 1 MG /10 MCG/ML INJECTABLE	05022019:90
SERMORELIN / IPAMORELIN 18 MG/ 15 MG LYOPHILIZED	05022019:34
SERMORELIN/GHRP-2 9 MG-6 MG LYOPHILIZED	05022019:47
SERMORELIN/GHRP-2/GHRP-6 9 MG/9 MG/9 MG LIQUID	05032019:29
LIPO MIC-12 METHIONINE/INOSITOL/CHOLINE/METHYLCOBALAMIN 10 ML 15 MG/50 MG/100 MG/1 MG INJECTABLE	05062019:09
IPAMORELIN ACETATE 9 MG INJECTABLE	05082019:91
SERMORELIN/GHRP-2 9 MG/9 MG LYOPHILIZED	05082019:92
SERMORELIN/GHRP-2 9 MG-6 MG LYOPHILIZED	05082019:78