Why it was recalled
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1113-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 76422 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LUPIN SOMERSET
Original FDA data
Every field from FDA enforcement report D-1113-2019, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82396
- Address
- 400 Campus Dr
- Code information
- 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.
- Postal code
- 08873-1145
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1113-2019
- Classification
- Class II
- Recalling firm
- LUPIN SOMERSET
- Product quantity
- 76422 bottles
- Termination date
- May 23, 2022
- Reason for recall
- Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 19, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 9, 2019