CLASS II Drug recall · Reported 8 Dec 2021 · FDA Enforcement Report
Biotin Solution for Injection, 10 mg/mL Multiple Dose Vial recalled
ASP Cares is recalling Biotin Solution for Injection, 10 mg/mL Multiple Dose Vial, Sterile, For IM or IV use only. The recall was initiated on 17 Nov 2021 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-0261-2022
- FDA event ID
- 89076
- Recalling firm
- ASP Cares, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2021
- FDA classified
- 26 Nov 2021
- Reported
- 8 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Nov 2021 | Recall initiated by company | |
| 26 Nov 2021 | Classified by FDA | +9 days |
| 8 Dec 2021 | Published in enforcement report | +12 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
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30
Where it was distributed
United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: 091721589 BUD: 03/16/2022
Where was it sold?
United States
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.
Other products in this recall event
2 other products · FDA event 89076This product is part of a recall event; the main page for the event is Ascorbic Acid Solution for Injection recalled by Asp Cares.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ascorbic Acid Solution for Injection recalled by Asp Cares | ASP Cares | Sterility | TX | |
| CLASS II | Methylcobalamin Solution for Injection recalled by Asp Cares | ASP Cares | Sterility | TX |
More recalls from ASP Cares
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin Solution for Injection recalled by Asp Cares | ASP Cares | Sterility | TX |
| Drug | CLASS II | Ascorbic Acid Solution for Injection recalled by Asp Cares | ASP Cares | Sterility | TX |
Other Biotin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Biotin for Injection, all strengths and presentations recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Biotin 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS III | Biotin 10 mg/mL Injection vial recalled by Auro Pharmacies | Auro Pharmacies | Other | Nationwide |
| Drug | CLASS II | Biotin Suspension 10mg/mL amber vial recalled | Partell Specialty Pharmacy | Sterility | NV |
| Drug | CLASS II | Biotin Injection, all strengths recalled by FVS Holdings | FVS Holdings | Sterility | Nationwide |