CLASS II Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report
Folic Acid injectable, 10 mg/ml Multiple Dose vial recalled
Auro Pharmacies is recalling Folic Acid injectable, 10 mg/ml Multiple Dose vial, distributed nationwide in the US. The recall was initiated on 21 Aug 2018 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-1166-2018
- FDA event ID
- 80890
- Recalling firm
- Auro Pharmacies, La Habra, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2018
- FDA classified
- 29 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Aug 2018 | Recall initiated by company | |
| 29 Aug 2018 | Classified by FDA | +8 days |
| 5 Sep 2018 | Published in enforcement report | +7 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: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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
Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Where it was distributed
Nationwide in USA
Stores named: Walmart
Questions about this recall
Is Folic Acid injectable, 10 mg/ml Multiple Dose vial recalled?
Yes. Auro Pharmacies recalled Folic Acid injectable, 10 mg/ml Multiple Dose vial on 21 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-1166-2018.
Why was it recalled?
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Which lots are affected?
Lot #: 180611/1, Exp 09-Sep-18
Where was it sold?
Nationwide in USA
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 Auro Pharmacies
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Biotin 10 mg/mL Injection vial recalled by Auro Pharmacies | Auro Pharmacies | Other | Nationwide |
| 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 | 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 |