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
Reported: August 25, 2021 Initiated: July 29, 2021 #D-0726-2021
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
Details
- Recalling Firm
- Novel Laboratories, Inc. d.b.a LUPIN
- Units Affected
- 20,814 bottles
- Distribution
- Nationwide
- Location
- Somerset, NJ
Frequently Asked Questions
What product 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. Recalled by Novel Laboratories, Inc. d.b.a LUPIN. Units affected: 20,814 bottles.
Why was this product recalled? ▼
Failed Stability Specification; Out of specification for Osmolarity
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0726-2021.
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