CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Acetic Acid Otic Solution recalled by Torrent Pharma
Torrent Pharma is recalling Acetic Acid Otic Solution, USP, 2%, distributed nationwide in the US. The recall was initiated on 21 May 2019 and the FDA has classified it as Class II.
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-1362-2019
- FDA event ID
- 82889
- Recalling firm
- Torrent Pharma, Levittown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2019
- FDA classified
- 13 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 21 May 2019 | Recall initiated by company | |
| 13 Jun 2019 | Classified by FDA | +23 days |
| 19 Jun 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Acetic Acid Otic Solution, USP, 2%, Rx Only, 15 mL bottle, NDC: 64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA 19057, Distributed by Rising Pharmaceuticals Ins Saddie Brook, NJ 07663.
Where it was distributed
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Questions about this recall
Is Acetic Acid Otic Solution, USP, 2% recalled?
Yes. Torrent Pharma recalled Acetic Acid Otic Solution, USP, 2% on 21 May 2019. The recall is Class II and its status is Terminated. Recall number D-1362-2019.
Why was it recalled?
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which lots are affected?
Lot #s: 18J005; 18J016; 18J025, Exp. 09/2020.
Where was it sold?
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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 Torrent Pharma
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|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium | Torrent Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled | Torrent Pharma | Potency & Assay | Nationwide |
Other Acetic acid otic recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetic Acid Otic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Acetic Acid Otic Solution recalled by Hi-Tech Pharmacal Co | Hi-Tech Pharmacal Co | Potency & Assay | Nationwide |