GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratori
Summary
The FDA issued a Class II for GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flav by Novel Laboratories, Inc. d.b.a LUPIN. Reason: Failed Stability Specification; Out of specification for Osmolarity.
Details
Source
Drug Recall
External ID
D-0726-2021
Action Date
2021-08-25
Status
Terminated
Category
drug
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
Lot/Code Info: Lot S001133, exp 7/2022
Quantity Affected: 20,814 bottles
Reason for Recall
Failed Stability Specification; Out of specification for Osmolarity
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-29
Company
Somerset, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Novel Laboratories, Inc. d.b.a LUPIN) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Novel Laboratories, Inc. d.b.a LUPIN have FDA actions?
This is the only FDA action we have on record for Novel Laboratories, Inc. d.b.a LUPIN in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0726-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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