Drug product
N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
D-0302-2021
Product summary
- Event
- Event 86617
- Status
- Terminated
- Classification
- Class II
- Quantity
- 533 units
- Official record key
drug-enforcement:D-0302-2021
Official wording
Reason: Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Code information: Lot 65323G20; Expiration: 7/22
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Mislabeling