D-0726-2021 Class II Terminated
FDA drug recall D-0726-2021 was initiated by Novel Laboratories, Inc. d.b.a LUPIN on July 29, 2021 and is designated Class II. Reason for recall: Failed Stability Specification; Out of specification for Osmolarity The recall status is terminated (terminated November 14, 2022). Affected quantity: 20,814 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 25, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- November 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,814 bottles
Product Description
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
Reason for Recall
Failed Stability Specification; Out of specification for Osmolarity
Distribution Pattern
Nationwide
Code Information
Lot S001133, exp 7/2022