CLASS III Drug recall · Reported 31 Aug 2016 · FDA Enforcement Report
Acetasol HC (hydrocortisone and acetic acid otic solution USP) recalled
Actavis is recalling Acetasol HC (hydrocortisone and acetic acid otic solution USP), distributed nationwide in the US. The recall was initiated on 2 Aug 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1471-2016
- FDA event ID
- 74902
- Recalling firm
- Actavis, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Aug 2016
- FDA classified
- 24 Aug 2016
- Reported
- 31 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 2 Aug 2016 | Recall initiated by company | |
| 24 Aug 2016 | Classified by FDA | +22 days |
| 31 Aug 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it 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).
Which lots are affected?
L503092, Exp 04/2016
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 74902| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Hydrocortisone and acetic acid otic solution recalled by Actavis | Actavis | Potency & Assay | Nationwide |
More recalls from Actavis
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Levofloxacin Ophthalmic Solution, 0.5%, Sterile recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Glipizide extended-release tablets, 2.5mg recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / Vials recalled | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS III | Hydrocortisone and acetic acid otic solution recalled by Actavis | Actavis | Potency & Assay | Nationwide |
| Drug | CLASS II | Glipizide 2.5 mg Extended-release tablets recalled by Actavis | Actavis | Potency & Assay | Nationwide |