CLASS III Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Biotin 10 mg/mL Injection vial recalled by Auro Pharmacies
Auro Pharmacies is recalling Biotin 10 mg/mL Injection vial, distributed nationwide in the US. The recall was initiated on 22 Mar 2019 and the FDA has classified it as Class III.
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-1082-2019
- FDA event ID
- 82483
- Recalling firm
- Auro Pharmacies, La Habra, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Mar 2019
- FDA classified
- 5 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Mar 2019 | Recall initiated by company | |
| 5 Apr 2019 | Classified by FDA | +14 days |
| 17 Apr 2019 | 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
Failed pH Specification: product does not meet pH label claim.
Product as listed by the FDA
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Biotin 10 mg/mL Injection vial recalled?
Yes. Auro Pharmacies recalled Biotin 10 mg/mL Injection vial on 22 Mar 2019. The recall is Class III and its status is Terminated. Recall number D-1082-2019.
Why was it recalled?
Failed pH Specification: product does not meet pH label claim.
Which lots are affected?
Lot 190205@1, expiry 08/4/19
Where was it sold?
Nationwide within the 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Auro Pharmacies
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcium Gluconate injectable, 10% Single Dose vial recalled | Auro Pharmacies | Sterility | Nationwide |
| Drug | CLASS II | Methyl-Cobalamin injectable, 10 mg/mL Multiple Dose vial recalled | Auro Pharmacies | Sterility | Nationwide |
| Drug | CLASS II | Folic Acid injectable, 10 mg/ml Multiple Dose vial recalled | Auro Pharmacies | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL recalled | Auro Pharmacies | Sterility | Nationwide |
| Drug | CLASS II | Methyl-Cobalamin injectable, 2 mg/mL Multiple Dose vial recalled | Auro Pharmacies | Sterility | Nationwide |