CLASS II Drug recall · Reported 7 Nov 2018 · FDA Enforcement Report
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas recalled
Pharm D Solutions is recalling Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas, distributed nationwide in the US. The recall was initiated on 10 Sep 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0137-2019
- FDA event ID
- 81002
- Recalling firm
- Pharm D Solutions, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Sep 2018
- FDA classified
- 1 Nov 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Sep 2018 | Recall initiated by company | |
| 1 Nov 2018 | Classified by FDA | +52 days |
| 7 Nov 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20
Where it was distributed
Nationwide
Questions about this recall
Is Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas recalled?
Yes. Pharm D Solutions recalled Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas on 10 Sep 2018. The recall is Class II and its status is Terminated. Recall number D-0137-2019.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: 04112018:83 Discard by: 10/8/2018; 03202018:48 Discard by: 9/16/2018; 04302018:91 Discard by: 10/27/2018
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pharm D Solutions
All 100| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Human Chorionic Gonadotropin 10,000 IU vials recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Nandrolone Decanoate 200 mg/mL Injectable vials recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin/Ghrp-2 & 6 (3-3-3 MG) vials, Pharm D recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | B-complex (Thiamine 100mg, Riboflavin 2mg recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin/Ghrp-2 9 mg/9 mg vials Pharm D recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |
Other Arginine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Arginine Hydrochloride Injection recalled by Fusion IV Pharmaceuticals | Fusion IV Pharmaceuticals | Foreign Material | Nationwide |