Drug product
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
D-1567-2019
Product summary
- Firm
- Wise Pharmacy
- Event
- Event 83397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 bottle
- Official record key
drug-enforcement:D-1567-2019
Official wording
Reason: Lack of Processing Controls
Code information: Lot #: 7131N, Exp 7/11/19
Distribution pattern: CO, TX, WY
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls