FDA Drug recall D-0726-2021
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc by Novel Laboratories D B A Lupin, citing failed Stability Specification; Out of specification for Osmolarity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0726-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-29 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novel Laboratories D B A Lupin |
| Distribution | US |
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
Reason
Failed Stability Specification; Out of specification for Osmolarity
Identifiers
| ndc | 43386-060-19 |
|---|---|
| code_info | Lot S001133, exp 7/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0726-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.