CLASS III Drug recall · Reported 8 May 2013 · FDA Enforcement Report
Acetic Acid Otic Solution recalled by Hi-Tech Pharmacal Co
Hi-Tech Pharmacal is recalling Acetic Acid Otic Solution, USP, distributed nationwide in the US. The recall was initiated on 11 Mar 2013 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-302-2013
- FDA event ID
- 65017
- Recalling firm
- Hi-Tech Pharmacal, Amityville, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Mar 2013
- FDA classified
- 30 Apr 2013
- Reported
- 8 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 11 Mar 2013 | Recall initiated by company | |
| 30 Apr 2013 | Classified by FDA | +50 days |
| 8 May 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
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
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
Which lots are affected?
Lot #: 610593, Exp 06/13
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.
More recalls from Hi-Tech Pharmacal
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Rx Choice Liquid Vitamin C recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal | Other | 13 states |
| Food | CLASS III | Rx Choice Liquid Vitamin C recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal | Other | 16 states |
| Food | CLASS II | Ferrous Sulfate Elixir 220 mg recalled by Hi-Tech Pharmacal CoFerrous Sulfate | Hi-Tech Pharmacal | Potency & Assay | 5 states |
| Drug | CLASS II | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled | Hi-Tech Pharmacal | Potency & Assay | Nationwide |
| Drug | CLASS III | Acyclovir Oral Suspension, USP 200 mg recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal | Potency & Assay | Nationwide |
Other Acetic Acid recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetic Acid Otic Solution recalled by Torrent Pharma | Torrent Pharma | Sterility | Nationwide |
| Drug | CLASS II | 0.25% Acetic Acid Irrigation USP (PIC) recalled by B. Braun MedicalAcetic Acid | B. Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetic Acid, Irrigation 3% Solution (1 Product) recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |