CLASS I ONGOING Drug recall · Reported 21 Jun 2017 · FDA Enforcement Report
Human Chorionic Gonadotropin, 15,000 IU per vial recalled
Complete Pharmacy and Medical Solutions is recalling Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, distributed nationwide in the US. The recall was initiated on 2 Apr 2016 and the FDA has classified it as Class I.
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-0918-2017
- FDA event ID
- 76681
- Recalling firm
- Complete Pharmacy and Medical Solutions, Miami Lakes, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 2 Apr 2016
- FDA classified
- 13 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Apr 2016 | Recall initiated by company | |
| 13 Jun 2017 | Classified by FDA | +437 days |
| 21 Jun 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
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, 15,000 IU per vial, lyophilized for injection, Rx only, Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
Which lots are affected?
Lot # 22016, Exp 1/30/2017
Where was it sold?
Nationwide and Puerto Rico
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Complete Pharmacy and Medical Solutions
All 6Other Human Chorionic Gonadotropin recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Human Chorionic Gonadotropin Injection, all strengths recalled | FVS Holdings | Sterility | Nationwide |