CLASS II Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Human Chorionic Gonadotropin 3000 IU recalled by Pharm D Solutions
Pharm D Solutions is recalling Human Chorionic Gonadotropin 3000 IU, distributed in Washington. The recall was initiated on 19 Nov 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-0343-2019
- FDA event ID
- 81629
- Recalling firm
- Pharm D Solutions, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2018
- FDA classified
- 20 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
Timeline
| 19 Nov 2018 | Recall initiated by company | |
| 20 Dec 2018 | Classified by FDA | +31 days |
| 26 Dec 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: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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
Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10
Where it was distributed
WA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Which lots are affected?
Lot: 10292018:21 Exp. 3/31/2019
Where was it sold?
WA
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 26 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 recalled by Pharm D Solutions | 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. Solutions recalled | Pharm D Solutions | Sterility | Nationwide |