Drug recall
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO…
FDA recall event 83397 · Class II · Wise Pharmacy
Key facts
| Event ID | 83397 |
|---|---|
| Recall numbers | D-1567-2019, D-1568-2019, D-1569-2019, D-1570-2019, D-1571-2019, D-1572-2019, D-1573-2019, D-1574-2019, D-1575-2019, D-1576-2019, D-1577-2019 |
| Recalling firm | Wise Pharmacy |
| Product type | Drugs |
| Products | Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123., Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123., Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123., Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123., Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123. and 6 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Processing Controls |
| Initiation date | Jul 22, 2019 |
| Report date | Aug 7, 2019 |
| Termination date | Feb 3, 2020 |
| City | Littleton |
| State | CO |
| Country | United States |
| FEI number | 3004995630 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: