D-1471-2016 Class III Terminated
FDA drug recall D-1471-2016 was initiated by Actavis Inc on Aug 2, 2016 and is designated Class III. Reason for recall: 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). The recall status is terminated (terminated Feb 8, 2017). Affected quantity: 672 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 31, 2016
- Initiation Date
- Aug 2, 2016
- Termination Date
- Feb 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 672 bottles
Product description
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
Reason for recall
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).
Distribution pattern
Nationwide and Puerto Rico
Code information
L503092, Exp 04/2016
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1471-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026