CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Human Chorionic Gonadotropin (ODT) recalled by KRS Global Biotechnology
KRS Global Biotechnology is recalling Human Chorionic Gonadotropin (ODT), distributed nationwide in the US. The recall was initiated on 16 Nov 2017 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-0173-2018
- FDA event ID
- 78553
- Recalling firm
- KRS Global Biotechnology, Boca Raton, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Nov 2017
- FDA classified
- 8 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 16 Nov 2017 | Recall initiated by company | |
| 8 Jan 2018 | Classified by FDA | +53 days |
| 17 Jan 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Product as listed by the FDA
Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Where it was distributed
Nationwide in the USA, Bermuda, and New Zealand
Questions about this recall
Is Human Chorionic Gonadotropin (ODT) recalled?
Yes. KRS Global Biotechnology recalled Human Chorionic Gonadotropin (ODT) on 16 Nov 2017. The recall is Class II and its status is Terminated. Recall number D-0173-2018.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Which lots are affected?
Lot: 06132017@22 BUD: 12/10/2017
Where was it sold?
Nationwide in the USA, Bermuda, and New Zealand
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 KRS Global Biotechnology
All 129| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | LIDOcaine HCl 2% (PF) 100 mg/ (20 mg/mL) Fill recalled | KRS Global Biotechnology | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine added to 5% Dextrose (PF) IV, 8 mg/ 032 mg/mL) recalled | KRS Global Biotechnology | Sterility | Nationwide |
| Drug | CLASS II | SUCCinylcholine Chloride (PF), 200 mg/ (20 mg/mL) Fill recalled | KRS Global Biotechnology | Sterility | Nationwide |
| Drug | CLASS II | Human Chorionic Gonadotropins Lyophilized For SC/IM Use recalled | KRS Global Biotechnology | Sterility | Nationwide |
| Drug | CLASS II | Cyclopentolate HCl 1% (5 mg/ / Phenylephrine HCl 5% 5 mg recalled | KRS Global Biotechnology | Sterility | Nationwide |