Reported Aug 31, 2016 · Terminated
Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis…
Actavis Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis Inc · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle
- Manufactured byActavis Midatlantic LLC 1877 Kawai Road Lincolnton, NJ 28092 USA, NDC 0472-0882-82
- Lot codes and dates
L503092Exp 04/2016
- Amount recalled
- 672 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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