Class II · Moderate risk Terminated
Boric Acid 600 mg per suppository
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Boric Acid 1% Ear Drop
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Boric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Recalling firm
- Western Drug
- Origin
- AZ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0399-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Boric recalls
See all
Class II · Moderate risk Terminated
Boric Acid 600 mg capsules
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
pH-D Feminine Health Boric Acid Vaginal Suppositories
Reason Marketed without an Approved NDA/ANDA.
Class II · Moderate risk Terminated
Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic…
Reason 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.
Class II · Moderate risk Terminated
All boric acid Products
Reason Lack of Processing Controls
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