CLASS II Drug recall · Reported 9 Oct 2019 · FDA Enforcement Report
Hydroxocobalamin 10 mg/ 5 mg/mL) fill in a Vial recalled
KRS Global Biotechnology is recalling Hydroxocobalamin 10 mg/ 5 mg/mL) fill in a Vial, distributed nationwide in the US. The recall was initiated on 12 Sep 2019 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-0062-2020
- FDA event ID
- 83789
- Recalling firm
- KRS Global Biotechnology, Boca Raton, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2019
- FDA classified
- 1 Oct 2019
- Reported
- 9 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Sep 2019 | Recall initiated by company | |
| 1 Oct 2019 | Classified by FDA | +19 days |
| 9 Oct 2019 | 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
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
Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337
Where it was distributed
Nationwide
Questions about this recall
Is Hydroxocobalamin 10 mg/ 5 mg/mL) fill in a Vial recalled?
Yes. KRS Global Biotechnology recalled Hydroxocobalamin 10 mg/ 5 mg/mL) fill in a Vial on 12 Sep 2019. The recall is Class II and its status is Terminated. Recall number D-0062-2020.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
All lots remaining within expiry.
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 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 |