Recalls / Class II
Class IID-1571-2019
Product
Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate, Nasal,, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Affected lot / code info
- Lot #: 7270N, Exp 7/22/2019
Why it was recalled
Lack of Processing Controls
Recalling firm
- Firm
- Wise Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6179 S Balsam Way Ste 150, N/A, Littleton, Colorado 80123-3095
Distribution
- Quantity
- 1 container
- Distribution pattern
- CO, TX, WY
Timeline
- Recall initiated
- 2019-07-22
- FDA classified
- 2019-07-31
- Posted by FDA
- 2019-08-07
- Terminated
- 2020-02-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1571-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.