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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

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

Agency Publication Date: November 2, 2018
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Summary

Pharm D Solutions, LLC is recalling 103,033 units of various sterile injectable and ophthalmic drug products, including medications like Acetylcysteine, Testosterone, and HCG. These products were produced under conditions that do not ensure they are free from microorganisms, which is a critical safety requirement for injectable and eye medications. While no specific injuries or adverse events were reported in the source data, the scale of the recall involves 79 different product types distributed nationwide. Consumers should verify if they possess any of the affected lots and contact their doctor immediately if they have used these medications.

Risk

The medications may be contaminated with bacteria or fungi due to a lack of sterility assurance. Using non-sterile injectable or eye medications can lead to serious, life-threatening infections, as these drugs bypass the body's natural defenses when injected or applied to the eyes.

What You Should Do

  1. Check your medication packaging for the manufacturer 'Pharm D Solutions' and verify the product name against the affected list, including common drugs like Testosterone in Grapeseed Oil, HCG, and various 'Tri-Mix' or 'Bi-Mix' injections.
  2. Identify the specific lot numbers and discard dates on your product labels; for example, check for Acetylcysteine Injection lot 07032018:93 (Discard by 01/03/2019) or Testosterone in Grapeseed Oil lot 01302018:77/A (Discard by 1/25/2019).
  3. Stop using any recalled medications immediately and do not administer any further doses.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative medications and to discuss any concerns if you have already used the affected products.
  5. Return any unused product to the pharmacy where it was purchased for a refund and contact Pharm D Solutions at their Houston, Texas location (1304 S Loop W) for further instructions.
  6. Report any adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program online or by calling 1-888-SAFEFDA (1-888-723-3332).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Acetylcysteine Injection 10 mg/5 mL (2 mg/mL)
Model:
NDC 69699-1424-10
Lot Numbers:
07032018:93 (Exp 01/03/2019)
07032018:27 (Exp 01/03/2019)
07032018:97 (Exp 01/03/2019)
Product: Arginine Injections 100 mcg/mL
Model:
NDC 69699-1414-20
Lot Numbers:
04112018:83 (Exp 10/8/2018)
03202018:48 (Exp 9/16/2018)
04302018:91 (Exp 10/27/2018)
Product: Ascorbic Acid 500 mg/mL Solution
Model:
NDC 69699-1502-50
Lot Numbers:
04252018:91 (Exp 10/21/2018)
Product: Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable
Model:
NDC 69699-1611-30
Lot Numbers:
06182018:55 (Exp 12/25/2018)
Product: Bacteriostatic Water for Injection 10 mL
Model:
NDC 69699-1417-10
Lot Numbers:
07182018:12 (Exp 1/14/2019)
04042018:68 (Exp 9/30/2018)
05152018:57 (Exp 11/10/2018)
06202018:17 (Exp 12/17/2018)
Product: Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL)
Model:
NDC 69699-1323-05
Lot Numbers:
04112018:34 (Exp 10/7/2018)
08012018:66 (Exp 1/28/2019)
07262018:34 (Exp 1/8/2019)
Product: Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL)
Model:
NDC 69699-1305-03
Lot Numbers:
04112018:37 (Exp 10/1/2018)
06202018:70 (Exp 12/16/2018)
08082018:95 (Exp 2/4/2019)
Product: Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL)
Model:
NDC 69699-1317-03
Lot Numbers:
04112018:50 (Exp 10/7/2018)
08082018:53 (Exp 2/4/2019)
Product: Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) Injectable & Powder
Model:
NDC 69699-1760-15
Lot Numbers:
04032018:49 (Exp 9/30/2018)
05242018:72 (Exp 11/20/2018)
06192018:08 (Exp 12/16/2018)
06132018:29 (Exp 12/10/2018)
Product: Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL
Model:
NDC 69699-1428-02
Lot Numbers:
07192018:88 (Exp 10/16/2018)
Product: Calcium Gluconate 1% Eyewash Oph. Soln (1000 mL)
Model:
NDC 69699-0907-10
Lot Numbers:
05072018:27 (Exp 5/2/2019)
07122018:11 (Exp 7/7/2019)
Product: Calcium Gluconate 1% Eyewash (125 mL)
Model:
NDC 69699-0906-12
Lot Numbers:
05072018:46 (Exp 5/1/2019)
07122018:30 (Exp 7/7/2019)
Product: Calcium Gluconate 10%, 100 mg/mL Injectable
Model:
NDC 69699-0914-30
Lot Numbers:
07312018:46 (Exp 1/27/2019)
07262018:97 (Exp 1/21/2019)
07122018:40 (Exp 1/8/2019)
Product: Calcium Gluconate 2.5% Inhal/Oral Soln
Model:
NDC 69699-0908-25
NDC 69699-0908-10
NDC 69699-0917-60
Lot Numbers:
05072018:40 (Exp 5/2/2019)
07262018:44 (Exp 1/22/2019)
07122018:83 (Exp 7/12/2019)
07262018:93 (Exp 1/22/2019)
07262018:81 (Exp 1/21/2019)
Product: Dexpanthenol Injection, 250 mg/mL
Model:
NDC 69699-1610-30
Lot Numbers:
08292018:08 (Exp 2/23/2019)
Product: Epi-Shugarcaine Kit Solution
Model:
NDC 69699-1409-60
Lot Numbers:
08272018:79 (Exp 10/1/2018)
Product: Epinepherine 1 mg/1 mL 3 mL Injectable
Model:
NDC 69699-0109-03
Lot Numbers:
07272018:17 (Exp 9/25/2018)
08292018:74 (Exp 10/28/2018)
Product: Glutamine 10 mg/mL Solution
Model:
NDC 69699-1439-59
Lot Numbers:
01402018:93 (Exp 10/10/2018)
07122018:16 (Exp 9/10/2018)
08302018:65
Product: Glutathione 200 mg/mL Solution
Model:
NDC 69699-1504-30
Lot Numbers:
08012018:94 (Exp 1/27/2019)
Product: Glycerin 72% (Lidocaine/Epi 2:1) Injectable
Model:
NDC 69699-1401-30
Lot Numbers:
07312018:13 (Exp 9/28/2018)
Product: HCG Lyophilized 5000 IU Injectable
Model:
NDC 69699-1707-10
Lot Numbers:
04252018:33 (Exp 10/21/2018)
05082018:39 (Exp 11/4/2018)
06262018:00 (Exp 12/23/2018)
07192018:13 (Exp 1/15/2019)
08012018:46 (Exp 1/28/2019)
08212018:69 (Exp 11/30/2018)
Product: HCG 10,000 unit/0.3 gm Mannitol Lyopholized
Model:
NDC 69699-1711-10
Lot Numbers:
04182018:46 (Exp 10/14/2018)
06072018:65 (Exp 12/3/2018)
05082018:01 (Exp 11/4/2018)
07282018:20 (Exp 1/24/2019)
Product: Lipo MIC-12 Compound Injectable
Model:
NDC 69699-1603-10
NDC 69699-1603-30
Lot Numbers:
09042018:66/A (Exp 3/3/2019)
07302018:65 (Exp 1/26/2019)
08132018:75/A (Exp 2/1/2019)
04172018:16 (Exp 9/30/2018)
03212018:27 (Exp 9/17/2018)
04242018:82 (Exp 10/20/2018)
05142018:72 (Exp 11/10/2018)
06192018:67 (Exp 12/18/2018)
08142018:00 (Exp 2/1/2019)
07302018:64 (Exp 1/26/2019)
Product: Methylcobalamin 1 mg/mL Injectable
Model:
NDC 69699-1501-10
NDC 69699-1501-30
Lot Numbers:
04242018:27 (Exp 9/15/2018)
04302018:55 (Exp 10/27/2018)
03192018:33 (Exp 9/15/2018)
05222018:28 (Exp 11/18/2018)
Product: Oxytocin 30 unit in LR 500 mL IV
Model:
NDC 69699-1203-50
Lot Numbers:
03152018:12 (Exp 6/13/2018)
04182018:08 (Exp 7/17/2018)
04302018:94 (Exp 7/29/2018)
03292018:44 (Exp 6/26/2018)
05212018:95 (Exp 8/19/2018)
06142018:46 (Exp 9/12/2018)
05312018:37 (Exp 8/29/2018)
06282018:80 (Exp 9/26/2018)
07312018:12 (Exp 10/29/2018)
07102018:53 (Exp 10/8/2018)
08222018:18 (Exp 11/20/2018)
Product: Testosterone in Grapeseed Oil 200 mg/mL
Model:
NDC 69699-1702-05
Lot Numbers:
01302018:77/A (Exp 1/25/2019)
09042017:74/B (Exp 8/30/2018)
04042018:51/A (Exp 3/31/2019)
05152018:94/A (Exp 5/9/2019)
07022018:04/A (Exp 6/27/2019)
07162018:80/B (Exp 7/11/2019)
08272018:15/B (Exp 8/22/2019)
12052017:13/B (Exp 11/30/2018)
09132017:58/A (Exp 9/7/2018)
01082018:40/B (Exp 1/3/2019)
Product: Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable
Model:
NDC 69699-1745-30
Lot Numbers:
02272018:63/A (Exp 2/22/2019)
08162018:63/A (Exp 4/30/2019)
10092017:30 (Exp 10/1/2018)
02272018:63 (Exp 2/22/2019)
08162018:63 (Exp 4/30/2019)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81002
Status: Resolved
Manufacturer: Pharm D Solutions, LLC
Sold By: Authorized pharmacies; Healthcare providers
Manufactured In: United States
Units Affected: 79 products (486 milliliters; 7150 milliliters; 10000 milliliters; 6000 milliliters; 285 vials; 130 milliliters; 148 milliliters; 115 milliliters; 29 vials; 567 milliliters; 25 bottles; 29 bottles; 6850 milliliters; 57 bottles; 2300 milliliters; 2000 milliliters; 70 bottles; 945 syringes; 1095 milliliters; 4000 milliliters; 180 milliliters; 2219 vials; 3 vials; 10 vials; 1171 vials; 881 vials; 765 vials; 2737 vials; 114 vials; 442 vials; 3000 milliliters; 896 vials; 64000 milliliters; 4 vials; 24500 milliliters; 264 vials; 1139 milliliters; 630 milliliters; 1900 milliliters; 193 milliliters; 154 milliliters; 189 milliliters; 600 milliliters; 25 milliliters; 517 syringes; 179 vials; 409 vials; 124 vials; 330 vials; 250 vials; 420 vials; 108 vials; 5000 milliliters; 12 bags; 10 bags; 3523 milliliters; 553 vials; 609 vials; 67 milliliters; 20 milliliters; 9 vials; 20 milliliters; 50 milliliters; 65 milliliters; 40 milliliters; 715 vials; 815 vials; 430 vials; 195 vials; 40 milliliters; 59 milliliters; 343 milliliters; 336 milliliters; 10 milliliters; 44 milliliters; 40 milliliters; 521 syringes; 12 bags; 184 vials; a) 4397, b) 4885 c) 1319, d) 4112 vials; 580 vials and 30000 milliliters)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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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.