Recalls / Class II
Class IID-1567-2019
Product
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Affected lot / code info
- Lot #: 7131N, Exp 7/11/19
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 bottle
- 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-1567-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.