GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specification; Out of specification for Osmolarity
What was recalled
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
- Recalling firm
- Novel Laboratories, Inc. d.b.a LUPIN
- NDC code
- 43386-060-19
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0726-2021
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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