Drug product
Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10
D-0136-2019
Product summary
- Event
- Event 81002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 486 milliliters
- Official record key
drug-enforcement:D-0136-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 07032018:93 Discard by: 01/03/2019; 07032018:27 Discard by: 01/03/2019; 07032018:97 Discard by: 01/03/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility