Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Hydrocortisone and acetic acid otic solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
What was recalled
Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Actavis Inc. 60 Columbia Road Bldg B. Morristown, NJ 07560 USA , NDC 45963-412-61
- Recalling firm
- Actavis Inc
- NDC code
- 45963-412-61
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1472-2016
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 Hydrocortisone recalls
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Class II · Moderate risk Ongoing
Med Pride
Reason CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk Terminated
Essential Calming Skin Gel
Reason Subpotent Drug
Class III · Low risk Terminated
Skin Rehab
Reason Subpotent Drug
Class III · Low risk Terminated
Remedy Gel
Reason Subpotent Drug
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