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

FDA recall notice · announced August 25, 2021 · Novel Laboratories, Inc. D.b.a Lupin

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

Failed Stability Specification; Out of specification for Osmolarity

Notes

Distribution: Nationwide
Lot/code information: Lot S001133, exp 7/2022
Quantity: 20,814 bottles
Status: Terminated
Products in this recall event:
- 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. Ba (D-0726-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.