Drug recall D-0726-2021
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
Lots and codes
Lot S001133, exp 7/2022
Recall details
- Recalling firm
- Novel Laboratories, Inc. d.b.a LUPIN, Somerset, NJ
- Quantity
- 20,814 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 29, 2021
- Terminated
- November 14, 2022
Related products
- GaviLyte - C – drug information
- NDC 43386-060 GaviLyte - C TM · Polyethylene Glycol 3350 240 g/278.26g; Sodium Chloride… · Lupin Pharmaceuticals,Inc.