Drug product
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19
D-0726-2021
Product summary
- Event
- Event 88390
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,814 bottles
- Official record key
drug-enforcement:D-0726-2021
Official wording
Reason: Failed Stability Specification; Out of specification for Osmolarity
Code information: Lot S001133, exp 7/2022
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification