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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pharm D Solutions, LLC: Injectable Medications and Water Recalled for Lack of Sterility Assurance

Agency Publication Date: June 7, 2019
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Summary

Pharm D Solutions, LLC is recalling approximately 3,274 units of various injectable medications and bacteriostatic water due to a lack of sterility assurance. These products, which include treatments like Testosterone, Human Chorionic Gonadotropin (HCG), and B-complex vitamins, may not be sterile, which can lead to serious health complications when injected. These medications were distributed nationwide within the United States in various vial sizes ranging from 5 mL to 30 mL. Consumers should stop using these products and contact their healthcare provider immediately.

Risk

A lack of sterility in injectable products means the medication may contain microorganisms like bacteria or fungi. When a non-sterile product is injected directly into the body, it poses a significant risk of causing life-threatening infections, sepsis, or localized abscesses.

What You Should Do

  1. Immediately check your medication vials for the Pharm D. Solutions brand name and address (1304 South Loop West, Houston, TX 77054).
  2. Verify if your product matches one of the affected lots, such as Bacteriostatic Water lot 11292018 (Exp 05/28/2019), Testosterone lot 10242018:70/B (Exp 08/31/2019), or B-complex lot 04032019:23 (Exp 06/11/2019).
  3. Stop using any of the affected medications or water vials immediately to prevent the risk of infection.
  4. Contact your healthcare provider or pharmacist to discuss your health concerns and to obtain a safe replacement medication.
  5. Return any unused vials to the pharmacy where you purchased them for a refund.
  6. Contact Pharm D. Solutions at 1-844-263-6846 for further instructions regarding the return of these products.
  7. Call the FDA Consumer Complaint hotline for additional questions at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

How to: Consumers should stop using the product and return unused portions to the place of purchase.

Affected Products

Product: Bacteriostatic Water for Injection (10 mL)
Model:
D-1322-2019
Lot Numbers:
11292018:75 (Exp. 05/28/2019)
01022019:70 (Exp. 07/01/2019)
02042019:04 (Exp. 08/03/2019)
03042019:94 (Exp. 08/31/2019)
Date Ranges: Exp. 05/28/2019, Exp. 07/01/2019, Exp. 08/03/2019, Exp. 08/31/2019
Product: B-complex (Thiamine, Riboflavin, Niacinamide, Pyridoxine, Depanthenol) injectable (10 mL)
Model:
D-1323-2019
NDC 69699-1611-30
Lot Numbers:
04032019:23 (Exp. 06/11/2019)
Date Ranges: Exp. 06/11/2019
Product: Human Chorionic Gonadotropin (10,000 IU)
Model:
D-1324-2019
Lot Numbers:
02052019:42 (Exp. 08/03/2019)
Date Ranges: Exp. 08/03/2019
Product: Human Chorionic Gonadotropin (5,000 IU)
Model:
D-1325-2019
Lot Numbers:
01082019:88 (Exp. 07/06/2019)
03182019:58 (Exp. 09/14/2019)
Date Ranges: Exp. 07/06/2019, Exp. 09/14/2019
Product: Human Chorionic Gonadotropin (12,000 IU)
Model:
D-1326-2019
Lot Numbers:
01232019:86 (Exp. 07/22/2019)
04042019:86 (Exp. 10/01/2019)
Date Ranges: Exp. 07/22/2019, Exp. 10/01/2019
Product: Ipamorelin Acetate Injectable (9 mg/9mL)
Model:
D-1327-2019
Lot Numbers:
05022019:50 (Exp. 10/29/2019)
05082019:91 (Exp. 06/08/2019)
Date Ranges: Exp. 10/29/2019, Exp. 06/08/2019
Product: Lipo MIC-12 Injectable (10 mL)
Model:
D-1328-2019
Lot Numbers:
02202019:53/A (Exp. 08/18/2019)
04012019:67/A (Exp. 09/28/2019)
04022019:47/A (Exp. 09/28/2019)
04042019:04/A (Exp. 09/30/2019)
04082019:38/A (Exp. 10/02/2019)
04302019:49/A (Exp. 10/27/2019)
05062019:09 (Exp. 11/02/2019)
Date Ranges: Exp. 08/18/2019, Exp. 09/28/2019, Exp. 09/30/2019, Exp. 10/02/2019, Exp. 10/27/2019, Exp. 11/02/2019
Product: Nandrolone Decanoate Injectable (200 mg/mL, 10 mL)
Model:
D-1329-2019
Lot Numbers:
01312019:34 (Exp. 07/30/2019)
Date Ranges: Exp. 07/30/2019
Product: Sermorelin/Ipamorelin (18 mg/15 mg, 10mL)
Model:
D-1330-2019
Lot Numbers:
04162019:48 (Exp. 10/13/2019)
04302019:70 (Exp. 10/27/2019)
05022019:34 (Exp. 10/29/2019)
Date Ranges: Exp. 10/13/2019, Exp. 10/27/2019, Exp. 10/29/2019
Product: Sermorelin/GHRP-2 (9 mg/9 mg)
Model:
D-1331-2019
Lot Numbers:
05082019:92 (Exp. 06/04/2019)
Date Ranges: Exp. 06/04/2019
Product: Sermorelin/GHRP-2 (9 mg/6 mg)
Model:
D-1332-2019
Lot Numbers:
03052019:43 (Exp. 08/31/2019)
04042019:15 (Exp. 10/01/2019)
04172019:08 (Exp. 08/31/2019)
05022019:47 (Exp. 10/30/2019)
05082019:78 (Exp. 06/04/2019)
Date Ranges: Exp. 08/31/2019, Exp. 10/01/2019, Exp. 10/30/2019, Exp. 06/04/2019
Product: Sermorelin/GHRP-2 & 6 (3-3-3 MG)
Model:
D-1333-2019
Lot Numbers:
12062018:17 (Exp. 06/04/2019)
Date Ranges: Exp. 06/04/2019
Product: Sermorelin/GHRP-2 & 6 (9-9-9 mg) [D-1334]
Model:
D-1334-2019
Lot Numbers:
05032019:29 (Exp. 11/02/2019)
Date Ranges: Exp. 11/02/2019
Product: Sermorelin/GHRP-2 & 6 (9-9-9 mg) [D-1335]
Model:
D-1335-2019
Lot Numbers:
02182019:79 (Exp. 08/17/2019)
04162019:86 (Exp. 10/13/2019)
Date Ranges: Exp. 08/17/2019, Exp. 10/13/2019
Product: Testosterone (200 mg/mL, 30 mL)
Model:
D-1336-2019
NDC 69699-1702-30
Lot Numbers:
10242018:70/B (Exp. 08/31/2019)
10302018:63/A (Exp. 08/31/2019)
Date Ranges: Exp. 08/31/2019
Product: Testosterone Cyp/Pro 95/5% (10 mL)
Model:
D-1337-2019
Lot Numbers:
01312019:02 (Exp. 08/16/2019)
02072019:45/A (Exp. 11/30/2019)
Date Ranges: Exp. 08/16/2019, Exp. 11/30/2019
Product: Testosterone Cypionate (200 mg/mL, 5 mL and 10 mL)
Model:
D-1338-2019
NDC 69699-1702-10
Lot Numbers:
10242018:70/P (Exp. 08/31/2019)
10242018:70/A (Exp. 08/31/2019)
02262019:49/A (Exp. 11/30/2019)
Date Ranges: Exp. 08/31/2019, Exp. 11/30/2019
Product: Trimix (30 mg Papaverine, 1mg phentolamine mesylate, 30 mcg alprostadil) Injectable (5 mL)
Model:
D-1339-2019
Lot Numbers:
05022019:90 (Exp. 07/13/2019)
Date Ranges: Exp. 07/13/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82941
Status: Resolved
Manufacturer: Pharm D Solutions, LLC
Sold By: Pharm D Solutions, LLC; Pharmacies
Manufactured In: United States
Units Affected: 18 products (716 vials; 4 vials; 26 vails; 279 vials; 104 vials; 11 vials; 669 vials; 50 vials; 24 vials; 6 vials; 66 vials; 100 vials; 1 vial; 25 vials; 704 vials; 371 vials; a) 114 vials and b) 566 vials; 4 vials)
Distributed To: Nationwide

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.