Recalls / Class II
Class IID-1113-2019
Product
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b) Orange Flavor Pack net wt. 2 g UPC 343386202027 c) Cherry Flavor Pack net wt. 2 g UPC 3433862034
- Brand name
- Gavilyte-n
- Generic name
- Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium Bicarbonate
- Active ingredients
- Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
- Route
- Oral
- NDC
- 43386-050
- FDA application
- ANDA090019
- Affected lot / code info
- Lot #: a) S800021, Exp 30-Nov-20; b) S800175, Exp 31-Dec-20; c) S 800401, Exp 28-Feb-21; S800426, Exp 31-Mar-21; S800920, Exp 31-Aug-21.
Why it was recalled
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Recalling firm
- Firm
- LUPIN SOMERSET
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 76422 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-03-19
- FDA classified
- 2019-04-09
- Posted by FDA
- 2019-04-17
- Terminated
- 2022-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1113-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.