CLASS II Drug recall · Reported 7 Aug 2019 · FDA Enforcement Report
Acetylcysteine 2% Otic Drop recalled by Wise Pharmacy
Wise Pharmacy is recalling Acetylcysteine 2% Otic Drop, distributed in Colorado, Texas, Wyoming. The recall was initiated on 22 Jul 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-1567-2019
- FDA event ID
- 83397
- Recalling firm
- Wise Pharmacy, Littleton, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jul 2019
- FDA classified
- 31 Jul 2019
- Reported
- 7 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Compounded Drugs
Timeline
| 22 Jul 2019 | Recall initiated by company | |
| 31 Jul 2019 | Classified by FDA | +9 days |
| 7 Aug 2019 | 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
Lack of Processing Controls
Product as listed by the FDA
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Where it was distributed
CO, TX, WY
Questions about this recall
Why was it recalled?
Lack of Processing Controls
Which lots are affected?
Lot #: 7131N, Exp 7/11/19
Where was it sold?
CO, TX, WY
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 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
10 other products · FDA event 83397This product is part of a recall event; the main page for the event is Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL recalled.
More recalls from Wise Pharmacy
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Alprostadil 100 mcg/mL Injectable vial recalled by Wise Pharmacy | Wise Pharmacy | Other | CO, TX, WY |
| Drug | CLASS II | Gentamicin (GU) Irrigation 240 mg/ Solution Container recalled | Wise Pharmacy | Other | CO, TX, WY |
| Drug | CLASS II | Tobramycin Irrigation 80 mg/ Solution Container, Refrigerate, Nasal recalled | Wise Pharmacy | Other | CO, TX, WY |
| Drug | CLASS II | Dexamethasone Sodium Phosphate PF 24 mg/mL Injection recalled | Wise Pharmacy | Other | CO, TX, WY |
| Drug | CLASS II | Papaverine/Phentolamine 30 mg/1 mg/mL Injectable Vial recalled | Wise Pharmacy | Other | CO, TX, WY |