Drug product
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
D-1471-2016
Product summary
- Firm
- Actavis Inc
- Event
- Event 74902
- Status
- Terminated
- Classification
- Class III
- Quantity
- 672 bottles
- Official record key
drug-enforcement:D-1471-2016
Official wording
Reason: 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).
Code information: L503092, Exp 04/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification